araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: NGS Genome Analysis in Personalisation of Lung Cancer Treatment

Summary: The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted treatment and genetic profiling of the disease. EGFR tyrosine kinase inhibitors (TKIs) confer remission in some patients, but use of the EGFR-TKIs is limited to patients with adenocarcinomas who have known activating EGFR mutations. And resistance to TKI treatment has become an increasingly important cause of treatment failure. Therefore, identification of the molecular components involved could lead to the development of effective therapy. Today only a limited number of genetic alterations are studied.
  Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical and therapeutic decision-making in oncology owing to its enhanced sensitivity in DND mutation detection.


Eligibility: Inclusion Criteria:
  -  patients of bronchial adénocarcinoma with metastases can benefit from first-line therapy - targeted therapy by tyrosine kinase inhibitor(TKI) for EGFR mutation and chemotherapy for non EGFR mutation)
  -  Patients with epidermoid cancer of the lungs can benefit from chemotherapy
  -  man and women
  -  age ≥ 18 years
  -  Patients have signed a written informed consent form
  -  Patients are affiliated to s social health insurance
  Exclusion Criteria:
  -  Survival time ≤ 3 months
  -  Patients with cerebral metastases
  -  Patients could not benefit from treatment for others diseases
  -  Pregnancy or breast-feeding
  -  Incapacity to sign the consent form for psychiatric, behavioural disorders
  -  Private individuals of freedom or under tutelage

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer

Summary: Although anti-HER2 (human epidermal growth factor receptor 2) therapy is currently approved for breast, gastric, and gastroesophageal cancers overexpressing the HER2 protein or amplified for the HER2 gene, HER2 aberrations (gene amplification, gene mutations, and protein overexpression) are reported in other diverse malignancies. Indeed, about 1-37% of tumors of the following types harbor HER2 aberrations: bladder, cervix, colon, endometrium, germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct.
  Lapatinib is an orally active, reversible, small molecule TKI that potently inhibits both ErbB1 and ErbB2 tyrosine kinase activity. Data suggest that a dual ErbB1 and ErbB2 inhibitor may provide improved therapeutic benefit compared with inhibitors that target only one or the other receptor.
  Therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients with HER2-positive refractory cancer.


Eligibility: Inclusion Criteria:
  -  Age > 19
  -  Written informed consent
  -  ECOG 0-2,
  -  Histologically confirmed HER2-positive Refractory solid tumor(IHC 3+ alone, or IHC 2+ with FISH amplification) and/or specific sensitivity to Lapatinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  -  The presence of measurable disease as defined by the Response (Evaluation Criteria in Solid Tumors (RECIST) version 1.1)
  -  Adequate organ function
  Exclusion Criteria:
  -  Uncontrolled symptomatic brain metastasis,Uncontrolled active infection
  -  Uncontrolled systemic illness (DM, CHF, unstable angina, hypertension or arrhythmia)
  -  Prolonged QT interval in ECG (QTc >450 msec)
  -  Pregnant, lactating women
  -  Prior treatment with lapatinib,Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication
  -  Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer

Relevance to patient case: possibly relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Perioperative Chemotherapy With Herceptin For Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis

Summary: Stage I：preoperative therapy
  -  Capecitabine plus oxaliplatin with herceptin is superior to surgery alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis; Stage II: Perioperative therapy
  -  Perioperative Capecitabine plus oxaliplatin with herceptin is superior to adjuvant Capecitabine plus oxaliplatin alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis;

Detailed description: The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with herceptin to improves R0 resection rate and survival among patients with potentially resectable HER-2 positive gastric cancer with liver metastasis.

Eligibility: Inclusion Criteria:
  -  1.Pathological tissue were gastric cancer by gastric and liver biopsy.
  2.Immunohistochemistry confirmed HER-2 (+)or FISH(+).
  3.gastric cancer with liver metastasis were not able to resectable lesions.
  4.Patients•had not received radiotherapy past and not other organ metastasis and peritoneal metastasis.
  5.ECOG performance status 0-1.
  6.Inadequate hematopoietic function： Hemoglobin≥90g/L; ANC≥1,500/mm3;Platelet≥100,000/mm3 7.Inadequate organ function which is defined as below: Total bilirubin≤1.5 pper limit of normal range (ULN); ALT / AST≤2.5 upper limit of normal range (ULN) (≤5.0 x ULN if hepatic metastasis); serum creatinine≤1.5 pper limit of normal range (ULN), Serum albumin≥30g/L.
  8.expectancy must be more than 3 months. 9.the random blood or urine pregnancy test in fertile woman must be the negative results in pregnancy test in 7 days.
  10.Patients for male and female used reliable contraception contraceptive method until the end of study 30 days later.
  11.The operation can complete the D2 operation(LNM≥15).
  12.LVEF≥50%
  Exclusion Criteria:
  -  1. Patients with other extrahepatic metastasis Include peritoneal metastasis.
  3. Patients with other malignancy in 5 years.
  4. Patients with peripheral nerve disease,two hydrogen pyrimidine dehydrogenase( DPD )deficiency,upper digestive tract obstruction or from malabsorption syndrome.
  5.Patients with hypertension failed to control, active bleeding, 3~4 proteinuria, heal the wound, romboembolism, heart failure, clinical symptoms of heart disease.
  6.Patients have obvious peripheral nervous system disorders,mental disorders and disorders of the central nervous system history.
  7.Patients have history of organ transplantation.
  8.Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study.
  9.Patients combined antitumor drug outside the research program.

Relevance to patient case: possibly relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Dose Escalation Study of ADXS31-164 in Subjects With HER2 Expressing Solid Tumors

Summary: This is a Phase 1b, multicenter, open-label, dose-escalation study designed to estimate the maximum tolerated dose (MTD) and determine the recommended Phase 2 dose (RP2D) of ADXS31-164. Once the RP2D has been selected, up to 4 expansion cohorts will be evaluated.


Eligibility: Inclusion Criteria:
  -  HER2 Positive
  -  Have histological or cytological diagnosis of locally advanced/metastatic HER2 solid tumors that has progressed or become intolerant to standard therapy or for which no standard therapy is available
  -  Have measurable and/or evaluable disease based on RECIST 1.1.
  -  ECOG performance status of 0 to 1
  Exclusion Criteria:
  -  Is newly diagnosed with a curative treatment option available.
  -  Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of' immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  -  Has had a prior monoclonal antibody therapy within 2 weeks prior to study Day 1. (Prior anti-HER2 therapy is acceptable).
  -  Has received anticancer chemotherapy, surgical treatment, and/or radiation therapy (except palliative radiation therapy for disease-related pain with a consult with the sponsor's medical monitor) within ≤2 weeks of first study treatment.
  -  Is dependent on, currently or has received within the past 4 weeks corticosteroids (hormone replacement therapy, topical corticosteroids and occasional inhaled corticosteroids are allowed).
  -  Has a contraindication to administration of trimethoprim/sulfamethoxazole or ampicillin.
  -  Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device and/or implant.

Relevance to patient case: possibly relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: The Expression of ZEB1 in CTCs Associated With Metastasis and Recurrence for Gastric Cancer

Summary: The aim of this study was to investigate the expression of ZEB1 in CTCs for gastric cancer, its correlation with the clinicopathology of gastric cancer, and the role of ZEB1 in invasion and metastasis in gastric cancer.

Detailed description: Invasion and metastasis of tumors and postoperative recurrence are the main causes of death in patients with gastric cancer and are also the key factors affecting the clinical treatment and prognosis.
  In this study, the investigators will detect the expression of ZEB1 in different types of CTCs(epithelial,mesenchymal and mixed phenotype) for gastric cancer by CanPatrolTM2 detection technology.Our investigation of the relationship between ZEB1 and the occurrence and development as well as the invasion and metastasis of gastric cancer is expected to provide data for the prognosis and targeted therapy of gastric cancer.
  Approximate 100 consecutive patients with gastric cancer and CTCs(+) will be enrolled in this study.Detection of ZEB1 expression in CTCs at baseline will show the relationship between ZEB1 and clinicopathological variables. Postoperative follow-up of ZEB1 expression in CTCs will be performed every three months in the first year and every six months in the following two years. The results may indicate the role of ZEB1 in CTCs about invasion and metastasis for gastric cancer .The aim of this study is to clarify the clinical significance of ZEB1 expression in CTCs for gastric cancer.

Eligibility: Inclusion Criteria:
  1. Pathologically proven gastric cancer and CTCs(+).
  2. Age:older than 18 years old,younger than 80 years old.
  3. cT1-4a(surgically resectable tumor),N0-3,M0 at preoperative evaluation according to the American Joint Committee on Cancer(AJCC) Cancer Staging Manual Seventh Edition.
  4. No obvious surgical contraindications.
  5. American Society of Anesthesiology (ASA) score class I, II, or III.
  6. Written informed consent.
  Exclusion Criteria:
  1. Severe mental disorder.
  2. Pregnancy.
  3. History of previous gastrectomy,endoscopic mucosal resection or endoscopic submucosal dissection.
  4. History of unstable angina or myocardial infarction within past six months.
  5. History of previous neoadjuvant chemotherapy or radiotherapy.
  6. History of other malignant disease within past 5 years.

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Study to Determine the Antibody Response to 500µg G17DT in Treatment of Patients With Gastric Cancer

Summary: This study was designed to investigate the antibody response generated by a 500µg dose of G17DT in patients with gastric cancer.

Detailed description: Another study, GC2, initiated prior to the start of this study investigated the appropriate dose and dosing schedule for G17DT in patients with Stage I-III gastric cancer. The highest dose tested in the GC2 study was 250µg. This dose was well tolerated but was not considered sufficiently immunogenic. Since tolerability had not constrained dosing up to 250µg, the GC5 study was designed to investigate a 500µg dose administered as a regimen of 0, 2, and 6 weeks.

Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed UICC Stage I, II or III gastric adenocarcinoma.
  -  Patients must have had a macroscopically curative resection for gastric cancer with absence of metastatic disease at the time of entry to the trial.
  -  Male or Female patients aged 18 years or older.
  -  Life expectancy of at least 3 months.
  -  WHO Performance Status of 0 to 1.
  -  Written informed consent
  Exclusion Criteria:
  -  Gastric surgery within four weeks of baseline (Week 0, visit 2) or gastric surgery anticipated during the period of the study.
  -  History of other malignant disease within the previous five years, except nonmelanomatous skin cancer or in situ carcinoma of the uterine cervix.
  -  Previous use within the last four weeks, concomitant use of anticipated use in the period of study, of any anti-cancer therapies.
  -  Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids.
  -  Females who were pregnant, planning to become pregnant or lactating.
  -  Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study.
  -  Previous G17DT treatment.
  -  Haematologicial indicators:
  Haemoglobin (Hb) < 10g/dL White blood cell count (WBC) < 4.0 x 10^9/L Platelets < 100 x 10^9/L

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Single-arm Study to Evaluate the Safety and Efficacy of Sunitinib, in Subjects With RET Fusion Positive or FGFR2 Amplification, Refractory Solid Tumors

Summary: This is a pilot study of sunitinib in patients with RET fusion positive or FGFR2 Amplification Refractory solid tumors.
  This study is a single-arm, pilot study of sunitinib in subjects with Refractory solid tumors harboring RET fusion positive or FGFR2 Amplification sunitinib 50mg will be administered orally once a day 42 days.Study treatment will be continued until objective disease progression.
  To investigate the efficacy of sunitinib in subjects with Refractory solid tumors harboring RET fusion positive or FGFR2 Amplification.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. RET fusion positive,FGFR amplification, Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
  4. ECOG performance status 0-2.
  5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
  6. Adequate Organ Function Laboratory Values
  -  Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 75 x 109/L
  -  bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
  -  creatinine ≤1.5 x UNL
  7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
  8. Adequate heart function.
  Exclusion Criteria:
  1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  2. Has known active central nervous system (CNS) metastases.
  3. Has an active infection requiring systemic therapy.
  4. Pregnancy or breast feeding
  5. Patients with cardiac problem.
  6. Any previous treatment with sunitinib

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer

Summary: This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the donafenib in advanced gastric cancer.

Detailed description: This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the tyrosine kinase inhibitor donafenib tosilate tablets (400 mg/d,200mg bid) in patients with advanced, inoperable gastric cancer progressing after chemotherapy . The primary endpoint is the safety.The secondary endpoints are tumor response and progression-free survival time.

Eligibility: Inclusion Criteria:
  -  All patients provided written, informed consent.
  -  Have histological or cytological documentation of gastric adenocarcinoma;
  -  Have received currently approved standard therapies and to have disease progression during or within 3 months after the last administration of the last standard therapy or to have stopped standard therapy because of unacceptable toxic effects.
  -  Standard therapies include as many of the following as were licensed: a fluoropyrimidine,oxaliplatin,irinotecan, paclitaxel,docetaxel;and trastuzumab for patients who had Her-2 positive tumours;
  -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  -  Life expectancy of at least 3 months;
  -  Have adequate bone-marrow, liver, and renal function at the start of the trial.
  -  Prothrombin time international normalized ratio≤1.5；
  Exclusion Criteria:
  -  Patients with brain metastases.
  -  Patients receiving cytotoxic chemotherapy, immunotherapy or hormonal therapy, radiotherapy to site of measurable or evaluable disease within the previous 4 weeks.
  -  Patients had evidence of clinically active interstitial lung disease or abnormal blood results by predefined criteria (serum bilirubin >1.5 times upper limit of reference range, aspartate or alanine aminotransferase>2.5 times the upper limit of normal if no demonstrable liver disease).

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Rociletinib (CO-1686) USA Expanded Access Program

Summary: To provide access to rociletinib for patients with advanced or metastatic EGFR-mutant NSCLC who have been treated previously with EGFR directed therapy and have evidence of a T790M mutation (T790M+).

Detailed description: This is an open-label, multi-center study in the US, which allows for expanded access to rociletinib for patients with advanced or metastatic, EGFR-mutant T790M+ NSCLC who were previously treated with at least one prior EGFR TKI therapy (≥2nd line). Patients will receive oral rociletinib twice daily on study as long as they have clinical benefit and until they have access to FDA-approved rociletinib.

Eligibility: Key Inclusion Criteria:
  -  Unresectable locally advanced or metastatic NSCLC with EGFR activating mutation (excluding exon 20 insertion) and presence of the T790M mutation
  -  Prior treatment with an approved or experimental EGFR-directed therapy
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  -  Adequate hematological and biological function
  -  Written informed consent on an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF before any study-specific evaluation
  Key Exclusion Criteria:
  -  Eligibility for other enrolling clinical trials of rociletinib
  -  Leptomeningeal carcinomatosis or other untreated or symptomatic CNS metastases (asymptomatic CNS metastases allowed if clinically stable without requirement for steroid dose increase for at least 4 weeks)
  -  History of prior interstitial lung disease
  -  Concurrent use of QT-prolonging medication
  -  Cardiac abnormalities:
  -  Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTcF) > 450 ms
  -  Inability to measure QT interval on ECG
  -  Personal or family history of long QT syndrome
  -  Implantable pacemaker or implantable cardioverter defibrillator
  -  Resting bradycardia < 55 beats/min
  -  Presence of serious or unstable concomitant systemic disorder incompatible with the clinical study (eg, substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism, and other active malignancy associated with life expectancy of less than 1 year)
  -  Pregnant or breastfeeding females and male or female patients who refuse to use adequate contraception during the study and for 12 weeks after the last dose of rociletinib
  -  Any contraindication, allergy, or hypersensitivity to rociletinib or excipients

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: HIPEC, Intravenous Chemotherapy and Surgery for the Treatment of Advanced GC With Peritoneal Metastasis

Summary: Explore the hyperthermic intraperitoneal chemotherapy (HIPEC) and intravenous chemotherapy for Creating the Operation Chance in advanced gastric cancer with peritoneal metastasis.

Detailed description: To assess the effectiveness and safety of Hyperthermic intraperitoneal chemotherapy, intravenous chemotherapy combined with surgery for the treatment of advanced gastric cancer with peritoneal metastasis,so as to further find out the optimal protocol for the Conversion therapy in the patients with advanced gastric cancer.

Eligibility: Inclusion Criteria:
  gastric cancer confirmed by endoscopic biopsy , and enhanced CT suspected to have peritoneal metastasis, including ascites, ovarian metastasis, omentum or peritoneal metastasis.
  -  Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary
  -  Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
  -  ECOG (Eastern Cooperative Oncology Group) : 0~2
  -  Age: 18~75 years old
  -  Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC>4.0×109/L, NEU >1.5×109/L, PLT>100×109/L, BIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value, and CRE<1.2mg/dl
  -  Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases
  -  Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver)
  -  Not participating in other study projects before and during the treatment
  -  Signed the Informed Consent Form
  Exclusion Criteria:
  -  Not conforming to above inclusion criteria
  -  Distal metastasis to lung, liver, or para aortic lymph node metastasis
  -  Ever operation on the stomach
  -  Operation intolerance due to other systemic basic diseases
  -  Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment
  -  Allergy to the drugs in this protocol
  -  Pregnant or lactating women
  -  Women at childbearing age and of pregnancy desire during the study

Relevance to patient case: not relevant