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

Clinical trial: A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2

Summary: This study will evaluate the efficacy and safety of intravenous RC48-ADC in local advanced or metastatic gastric patients with the overexpression of HER2.


Eligibility: Inclusion Criteria:
  -  Voluntary agreement to provide written informed consent.
  -  Male or female, Age ≥ 18 years and ≤ 80 years.
  -  Predicted survival ≥ 12 weeks.
  -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  -  All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically.Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.
  -  Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
  -  Adequate organ function.
  -  Have had progression or intolerance following receipt of at least two systemic chemotherapy for advanced or metastatic disease.
  -  HER2 overexpression defined as HER2 IHC 2+ or 3+.
  -  Measurable disease according to RECIST 1.1.
  Exclusion Criteria:
  -  Known hypersensitivity to Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
  -  History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.
  -  History of major surgery within 4 weeks of planned start of trial treatment.
  -  Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
  -  Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  -  History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
  -  Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

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

Clinical trial: Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay

Summary: Currently, publicly funded standard of care testing in Ontario for stage IV lung cancer patients uses individual gene tests to look for mutations in the EGFR and ALK genes. This testing broadens treatment options for patients, however there are other gene mutations with corresponding targeted treatments that are not routinely tested for. This study will evaluate the utility and added value of using a next generation sequencing (NGS) panel, the Oncomine Comprehensive Assay v3, to profile stage IV lung cancer patients.


Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years of age
  -  Pathologic or cytologic confirmation of lung adenocarcinoma (mixed adenocarcinoma and sarcomatoid features permitted)
  -  Stage IV disease
  -  Sufficient FFPE tumour tissue for OCCP testing
  -  Performance status 0-2
  -  Candidates for targeted therapy (TKIs) and/or clinical trials as determined by the patient's medical oncologist
  -  Prognosis > 6 months
  -  Known translocations of RET, MET exon14 skipping variants, or MET amplification are allowed
  Exclusion Criteria:
  ● Patients with known EGFR, KRAS, BRAF and ERBB2 mutations or ALK or ROS1 fusions at study entry unless acquired resistance to molecularly targeted therapy

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

Clinical trial: The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer

Summary: This is a randomized, open-label study done in 3 hospitals in China. Patients with stage IIIB and IIIC gastric cancer who undergo curative D2 gastrostomy will be randomly assigned after surgery to receive adjuvant chemotherapy with oxaliplatin and capecitabine, or adjuvant chemotherapy combined Traditional Chinese treatment. The primary outcome was disease-free survival and 3-year disease-free survival rate in the intention-to-treat population.

Detailed description: The purpose of this study is to evaluate the Traditional Chinese Medicine combined adjuvant chemotherapy in the treatment of stage IIIb and IIIc gastric cancer through randomized controlled trial.
  Metastasis and recurrence is the primary cause in decreasing the survival time of gastric cancer patients who experienced radical operation. Among whom, patients with stage IIIB and IIIC are especially in high risk of metastasis and recurrence, result in a significant poor survival time than patients with earlier stages.
  Oxaliplatin with capecitabine is the standard adjuvant chemotherapy for curative D2 gastrostomy gastric cancer, contribute the 3-year disease free survival rate of 74% in ITT, and 61% in stage IIIB sub-group. Meanwhile, Traditional Chinese Medicine (TCM) treatment has been used for thousands of years in Chinese clinical practices. In China, the clinical curative effect of TCM in the treatment of gastric cancer has been part of affirmation. Some reports with large samples of clinical research show that the TCM is effective and safety for gastric cancer.In order to evaluate efficacy on TCM combined adjuvant chemotherapy in IIIB and IIIC gastric cancer, we design this randomized, open-label study.

Eligibility: Inclusion Criteria:
  -  Histologically proven gastric carcinoma with radical operation, TNM (primary tumor, regional nodes, metastasis) stage IIIb or IIIc （The Eighth Edition American Joint Committee on Cancer [AJCC] gastric cancer staging）;
  -  Karnofsky performance status higher than 70;
  -  Adequate hepatic, renal, cardio and hematologic function;
  -  With patients' consent and comply to long term follow-up.
  Exclusion Criteria:
  -  Gastrectomy beyond D2, or TNM stage beyond Ⅲb and Ⅲc;
  -  Histological type beyond gastric carcinoma;
  -  Conversion chemotherapy before surgery;
  -  Concurrent cancer;
  -  Women of gravid or lactating; patients with mental illness;
  -  Uncontrolled significant comorbid conditions.

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

Clinical trial: Verifying the Specificity of a New Method in Predicting Lymph Node Metastasis in Early Gastric Cancer Patients

Summary: Early gastric cancer is defined as gastric cancer that only invades mucosal or submucosal layer. The 5-year survival rate of gastric cancer can exceed 90% due to appropriate treatment. The most important consideration is whether there is lymph node metastasis. Preoperative examination including gastroscopy, endoscopic ultrasonography (EUS) and CT are not accurate enough to predict lymph node metastasis in early gastric cancer. In a retrospective study, we created a nomogram to predict lymph node metastasis in early gastric cancer. In prospective validation, the sensitivity and specificity of the nomogram was 75% and 91%, respectively. Sentinel lymph node is a promising concept in early gastric cancer. Using carbon nanoparticles as tracer, the sensitivity and specificity of sentinel lymph node predicting lymph node metastasis in early gastric cancer were 90% and 100%. Based on these results, we proposed a new method that combines the Nomogram and sentinel lymph node to predict lymph node metastasis in early gastric cancer. First, the probability of lymph node metastasis of early gastric cancer patients is calculated by the Nomogram. Those with low incidence of lymph node metastasis continue to the sentinel lymph node procedure. A patient will be considered non lymph node metastasis if his/her frozen pathology of the sentinel lymph nodes is negative during the surgery. Then the standard radical gastrectomy is performed with lymphadenectomy. By comparing postoperative pathology and sentinel lymph node frozen pathology, the specificity of Nomogram combining sentinel lymph node predicting lymph node metastasis in early gastric patients is calculated. The primary endpoint of this research is that the specificity of the above-mentioned method is over 95%.


Eligibility: Inclusion Criteria:
  -  diagnosed as gastric cancer by gastroscopy
  -  pathologically confirmed as adenocarcinoma
  -  ages between 18 and 80
  -  gastroscopy, abdominal enhanced CT and EUS completed
  -  clinical stage T1N0M0
  -  the score of the Nomogram less than 110
  -  potential resectable gastric cancer
  -  signed informed consent
  Exclusion Criteria:
  -  absolute indication for endoscopic submucosal dissection (ESD)
  -  tumor located in esophagogastric junction (EGJ)
  -  accepted adjuvant therap
  -  pregnant or breast feeding
  -  history of upper abdominal surgery (laparoscopic cholecystectomy not included)
  -  history of gastric surgery
  -  emergency surgery such as perforation or obstruction
  -  other contraindication such as dysfunction of heart, lung, kidney

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

Clinical trial: Neoadjuvant Chemotherapy for Gastric Cancer in China

Summary: Safety and feasibility study of perioperative chemotherapy for gastric cancer patients in high volume center of China

Detailed description: Two systemic chemotherapy (FLOT Vs SOX) will be evaluated for safety and feasibility in gastric cancer patients of China. Primary endpoint and secondary endpoint is described above. The aim of this study to select a chemotherapy regimen for further study(Phase III).

Eligibility: Inclusion criteria
  -  Pathology confirmed gastric cancer with cTNM stage III
  -  Clinically fit for gastric cancer surgery
  Exclusion criteria:
  -  Clinically unfit for gastric cancer surgery
  -  Distant metastases

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

Clinical trial: Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC)

Summary: the purpose of this study is to evaluate application value of LCI in the diagnosis of early gastric cancer.

Detailed description: The detection rate of early gastric cancer is still very low in China. The investigators need a new and effective screening method to improve the detection rate. LCI (linked-color imaging)is a new model of laser endoscopy which can provide brighter image. LCI can provide clear image which can make red part redder and white part whiter, so suspicious lesion could be found easier. The study of this randomized controlled trial is to discuss effectiveness of LCI in the diagnosis of early gastric cancer and to find a new method to improve the detection rate of early gastric cancer in China.

Eligibility: Inclusion Criteria:
  1. High-risk group of gastric cancer: H. pylori infection; previously suffering from chronic atrophic gastritis, intestinal metaplasia, gastric ulcer, gastric polyps, residual stomach after surgery, hypertrophic gastritis, malignant anemia and other precancerous diseases of gastric cancer;
  2. First degree relatives of patients with gastric cancer;
  3. There are other high risk factors for gastric cancer (high salt, salted diet, smoking, heavy drinking, etc.).
  4. Patients with early gastric cancer treated with endoscopic therapy (ESD, EMR).
  5. The informed consent has been signed.
  Exclusion Criteria:
  1. The TNM classification of cancer is consistent with those diagnosed by T2 above.
  2. Patients with abnormal blood coagulation function or taking anticoagulants can not biopsy.
  3. There were contraindications for gastroscopy.
  4. A patient without self judgement;
  5. Those who did not sign informed consent.
  6. Previous gastroscopy has found suspicious lesions requiring careful examination.

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

Clinical trial: Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers

Summary: This is a Phase 1, open-label, multi-center study to assess safety and determine the recommended phase 2 dose (RP2D) of ACTR T cell product (ACTR707 or ACTR087) in combination with trastuzumab, following lymphodepleting chemotherapy in subjects with HER2-positive advanced malignancies.


Eligibility: Inclusion Criteria:
  -  Signed written informed consent obtained prior to study procedures
  -  Histologically-confirmed Her2 positive advanced solid tumor malignancy with documented disease progression during or immediately following the immediate prior therapy, or within 6 months of completing adjuvant therapy for subjects with breast cancer
  -  Subjects must have previously received adequate standard therapy for treatment of their malignancy
  -  For those with metastatic breast cancer, must have received HER2-directed therapy including trastuzumab, pertuzumab and ado-trastuzumab in any breast cancer disease setting
  -  For those with advanced gastric cancer, adequate prior treatment with HER2-directed chemotherapy is required
  -  At least 1 measurable lesion by iRECIST
  -  Able to provide fresh tumor biopsy or archived block specimen taken since time of most recent anti-HER2 mAb-directed therapy
  -  ECOG of 0 or 1
  -  Life expectancy ≥ 6 months
  -  LVEF ≥ 50% by MUGA or ECHO
  -  Absolute neutrophil (ANC) count ≥ 1500/ µL
  -  Platelet count ≥ 100,000/µL
  -  Hemoglobin ≥ 9g/dL
  -  Estimated GFR >30mL/min/1.73m2
  Exclusion Criteria:
  -  glioblastoma multiforme or other primary CNS tumors are excluded
  -  clinically significant cardiac disease
  -  clinically significant active infection
  -  clinical history, prior diagnosis, or overt evidence of autoimmune disease
  -  current use of more than 5mg/day of prednisone (or an equivalent glucocorticoid)
  -  Prior treatment as follows:
  -  prior cumulative doxorubicin dose greater than or equal to 300 mg/m^2 or equivalent
  -  chemotherapy within 2 weeks of enrollment
  -  external beam radiation within 2 weeks of enrollment (28 days if CNS-directed therapy)
  -  any monoclonal antibody (mAb) or other protein therapeutic containing Fc-domains within 4 weeks of enrollment
  -  pertuzumab within 4 months of enrollment
  -  Experimental agents within 3 half-lives or 28 days prior to enrollment, whichever is shorter
  -  allogeneic hematopoietic stem cell transplant (HSCT)
  -  prior infusion of a genetically modified therapy
  -  Pregnant or breastfeeding

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

Clinical trial: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT)

Summary: This is a global, randomized, double-blind, controlled study to evaluate the efficacy of bemarituzumab (FPA144) + mFOLFOX6 versus placebo + mFOLFOX6 in patients with FGFR2 selected Gastric Cancer (as determined by prospective IHC FGFR2b overexpression and/or a ctDNA blood assay demonstrating FGFR2 gene amplification)

Detailed description: The main purpose of this study is to evaluate the efficacy of bemarituzumab (FPA144), which is a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with Gastric Cancer as measured by overall survival.

Eligibility: Key Inclusion Criteria:
  -  Histologically documented gastric or gastroesophageal junctional adenocarcinoma (not amenable to curative therapy)
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  -  Adequate hematological, liver and kidney function. Measurable or non-measurable, but evaluable disease using RECIST v1.1
  -  FGFR2b overexpression as determined by a centrally performed IHC tissue test and/or FGFR2 gene amplification as determined by a centrally performed ctDNA blood based assay
  -  Candidate for mFOLFOX6 chemotherapy
  Key Exclusion Criteria:
  -  Untreated or symptomatic central nervous system (CNS) metastases
  -  Clinically significant cardiac disease,
  -  Peripheral sensory neuropathy >/= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
  -  Active infection requiring systemic treatment
  -  Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection
  -  Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
  -  Known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
  -  Known positivity for HER2
  -  Women who are pregnant or breastfeeding
  Note: Other protocol defined Inclusion/Exclusion criteria may apply

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

Clinical trial: Comparing the Prognosis of Patients With Cardia and Non-cardia Gastric Cancer.

Summary: To comparing the stage-for-stage prognosis of patients with cardia and non-cardia gastric cancer after operation.

Detailed description: The aim of this study is to compare the stage-for-stage prognosis of patients with cardia and non-cardia gastric cancer after operation.In this study, patients with cardiac and non-cardiac gastric cancer who undergo radical resection from January 2019 to December 2024 will be included. We will follow up the patient's progression, recurrence time and survival time of these patients

Eligibility: Inclusion Criteria:
  1. Histopathology or cytopathology proven cardia or non-cardia gastric cancer;
  2. Operable gastric cancer patients: primary lesions can be completely excision, no distant metastasis;
  3. Life expectancy of at least 6 months;
  4. ECOG（Eastern Cooperative Oncology Group ） score 0-1;
  5. Age: 18~80 years old;
  6. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function).
  For example: WBC（White blood cell count ）>4.0×109/L; NEU（Neutrophils）>1.5×109/L; PLT（Platelet）>100×109/L;
  7. Roughly normal cardiopulmonary function: No coronary heart disease, myocardial infarction, pulmonary heart disease, refractory hypertension;
  8. Not concomitant with other uncontrollable benign diseases before the recruitment;
  9. Voluntarily signed the informed consent.
  Exclusion Criteria:
  1. Advanced gastric cancer patients with distant metastasis and inoperable ;
  2. Pregnant or lactating women;
  3. Patients who have no desire to participate in the study.

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

Clinical trial: Advanced Refractory Solid Tumors With TP53 Mutations Register Study

Summary: The efficacy and safety of the PARP inhibitor in combination with the VEGFR inhibitor will be investigated in advanced refractory solid tumors patients with TP53 mutation .

Detailed description: TP53 is a well-known tumor suppressor gene. Multiple studies have demonstrated that TP53 mutations are poor prognostic factor in advanced solid tumor, the TP53 gene is frequently inactivated by mutation in a majority of human tumors. However, no effective TP53 -based therapy has been successfully translated into clinical cancer treatment. So, investigators intend to review and evaluate the efficacy and safety of the PARP inhibitor in combination with the VEGFR inhibitor for TP53 mutation in advanced refractory solid tumors patients from a real-world population.

Eligibility: Inclusion Criteria:
  1. Is equal to or greater than 18 years of age.
  2. Histologic or cytologic confirmation of advanced refractory solid tumors with no standard treatment options, including some patients with advanced disease in reduced general condition (Eastern Cooperative Oncology Group (ECOG) 3 and 4).
  3. Patients with measurable or evaluable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
  4. Patients must be able to provide blood samples or tissue samples for NGS (Next Generation Sequencing) testing for understanding the TP53 gene status. The amount of blood and tissue samples should be able to meet the requirements of DNA extraction and quality control.
  5. Adequate baseline organ system function.
  6. Patients could receive treatment program from MTB (Molecular Tumor Board).
  7. No prior treatment with PARP combined with VEGFR inhibitions.
  8. Ability to understand and the willingness to provide a written informed consent document.
  Exclusion Criteria:
  1. Women who are pregnant or breastfeeding.
  2. Prior anti-cancer therapy or radiation therapy within 2 weeks prior to enrolment. Palliative radiotherapy to metastatic lesion(s) permitted providing that it has been completed at least 2 days prior to enrolment and no significant toxicity are expected.
  3. Clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study enrollment; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.
  4. Active infection requiring systemic therapy.
  5. Patients unable to swallow orally administered medication.
  6. Prior treatment with PARP or VEGFR inhibitions.
  7. According to the investigator'judgment, there are serious, uncontrollable risks to patients'safety, or associated diseases (such as severe diabetes, thyroid disease, infection, spinal cord compression, superior vena cava syndrome, neurological or psychiatric disorders and so on) that affect the patients completion of the study.

Relevance to patient case: not relevant