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

Clinical trial: Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients

Summary: This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162.
  Study drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days.


Eligibility: Inclusion Criteria:
  -  Histologically/ cytologically confirmed, advanced non resectable solid tumors
  -  Measurable or non-measurable, but evaluable disease as determined by RECIST
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement.
  -  Diabetes mellitus
  -  Unacceptable ocular/retinal conditions

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

Clinical trial: TrasGEX™: Dose Escalation Study

Summary: This is a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of TrasGEX™ after intravenous administration in patients with HER-2 positive cancers. The effect of TrasGEX™ on the development of anti-drug antibodies and on tumour response will also be evaluated.


Eligibility: Main Inclusion Criteria:
  1. Signed written informed consent granted prior to initiation of any study-specific procedures;
  2. Male or female patients of ≥18 years of age;
  3. ERBB2 (HER-2) gene amplification or ERBB2 overexpression
  4. Histologically or cytologically confirmed cancer, either locally advanced or metastatic;
  5. No anti-tumor therapy of proven benefit available at study enrollment;
  6. Life expectancy of >=3 months;
  7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) <=2;
  8. Male or female patients of child-producing potential must agree to use contraceptive measures or oral contraception during the study and for 28 days after the last dose of TrasGEX™;
  9. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of TrasGEX™;
  and
  Main Exclusion Criteria:
  1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks of the first dose of TrasGEX™;
  2. Major surgery within four weeks of the first dose of TrasGEX™;
  3. Newly diagnosed brain metastases, metastases that have been documented to be stable for <3 months, or metastases for which systemic corticosteroids are required;
  4. History of allergic reactions attributed to compounds of similar chemical or biologic composition as TrasGEX™;
  5. History of myocardial infarction within 12 months of the administration of the first dose of TrasGEX™;
  6. History of congestive heart failure defined as Class II to IV per New York Heart Association classification within 12 months of the administration of the first dose of TrasGEX™;
  7. Left ventricular ejection fraction <50%;
  8. Previous malignancy other than the current diagnosis within 5 years of the first dose of TrasGEX™;
  9. Pregnancy or lactation; and
  10. Concurrent uncontrolled significant illness

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

Clinical trial: Sym004 in SCCHN Patients Failing Anti-EGFR Based Therapy

Summary: The trial is designed as a multi-center, open label Phase 2 trial that investigates the efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck (SCCHN). Subjects included must have responded to previous anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody-based therapy and subsequently become resistant to that therapy. It is believed that Sym004 has the potential to induce tumor responses and provide a superior treatment option to subjects with advanced SCCHN.
  Symphogen was the sponsor for planning/conducting and reporting results for this trial.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis initially or at relapse of SCCHN of the oral cavity, oropharynx, hypopharynx or larynx
  -  Recurrent and/or metastatic SCCHN not amenable to curative treatment with surgery and/or (chemo)radiation
  -  Previous treatment with an anti-EGFR monoclonal antibody (mAb) in the palliative setting either as monotherapy or in combination with chemotherapy or radiotherapy and showing:
  -  Documented clinical benefit or response for at least 8 weeks (PR, CR or SD) on the anti-EGFR mAb-based therapy and
  -  Documented disease progression (verified by computed tomography [CT] scan or magnetic resonance imaging [MRI] according to RECIST (1.1) during or within 12 weeks following the last administration of anti-EGFR mAb
  -  Accessible tumor for biopsy and subject acceptance of repeat tumor biopsies
  -  Other protocol-defined inclusion criteria could apply
  Exclusion Criteria:
  -  More than 2 lines of prior chemotherapy in the palliative setting
  -  Expected survival <12 weeks
  -  Subjects with known brain metastases
  -  Chemotherapy or radiation therapy within 21 days prior to Visit 2 at the exception of palliative radiotherapy for bleeding or pain, which is allowed anytime, if not given on target lesions
  -  Anti-EGFR mAbs within 14 days prior to Visit 2
  -  Major surgery within 4 weeks prior to Visit 2 and subjects must have recovered from effects of major surgery
  -  Other protocol-defined exclusion criteria could apply

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

Clinical trial: Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer

Summary: There are few reports on a dual dye and isotope approach using laparoscopy in gastric cancer sentinel node mapping.
  The aim of this study was to evaluate the feasibility of laparoscopic limited gastrectomy with sentinel basin(SB) dissection for gastric cancer using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections.

Detailed description: Prospective phase II clinical trials for sentinel node navigation surgery(SNNS) in early gastric cancer.
  Laparoscopic SNNS:
  1. ICG and 99mTc-antimony sulfur colloid (ASC) submucosal injection under intraoperative endoscopy
  2. Sentinel node basin identification and dissection
  3. Sentinel nodes picking in back table
  4. Frozen biopsy of sentinel nodes(hematoxylin and eosin staining and immunohistochemistry for cytokeratin)
  5. If the sentinel node biopsy by frozen section is negative, limited gastrectomy will be performed or if positive, radical D2 gastrectomy will be performed.
  Sample size: 100 cases
  Study duration: 5 years( 2year enrollment, 3 year follow-up)

Eligibility: Inclusion Criteria:
  -  Age 20-80
  -  Informed consent
  -  No other malignancies
  -  cT1N0 stage gastric cancers < 4cm
  -  no allergic history of isotope
  Exclusion Criteria:
  -  Patients eligible for endoscopic submucosal dissection(ESD) with absolute indication

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

Clinical trial: The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer

Summary: The aim of this study is to evaluate survival benefit of a neoadjuvant chemotherapy regimen in patient with resectable locally advanced gastric cancer in comparison with surgery alone.

Detailed description: Adenocarcinoma of the stomach ranks as the fourth most commonly diagnosed cancer and as the second leading cause of cancer-related death in the world. Radical resection with free-margin gastrectomy and extended lymphadenectomy is the preferred surgical strategy in Japan and Asian centers.
  Unfortunately, only one-half of surgically treated patients with gastric cancer will achieve a complete resection without residual disease (R0) resection. Moreover, due to, the absence of routine screening programs for gastric cancer, the majority of the patients will be symptomatic at the time of diagnosis in our country.
  Additionally, recent treatment strategies were focused for downsizing or decreasing to loco-regional recurrence.
  In this reason, we hypothesize that preoperative chemotherapy may improve the R0 resection rate or disease free and/or overall survival rate.

Eligibility: Inclusion Criteria:
  -  Histologically proven adenocarcinoma of stomach
  -  T3 or T4
  -  N1 or N2
  -  M0
  -  No evidence of para-aortic or retropancreatic lymph node metastasis, peritoneal dissemination or Krukenberg tumor.
  -  No involvement of the esophagus with > 2cm
  -  An age of 18-90 years
  -  A Karnofsky Performance status with 60-100% or Eastern Cooperative Oncology Group (ECOG) performance status (0-2)
  -  No previous chemotherapy, radiotherapy for any malignancy.
  -  No previous surgery for gastric cancer
  -  No evidence obstructive or bleeding symptoms.
  -  Adequate renal and hepatic function
  -  Written informed consent
  Exclusion Criteria:
  -  Synchronous or metachronous malignancy diagnosing within 5 year
  -  Pregnancy or lactation in female patients
  -  Any immunosuppressive condition (acquired or iatrogenic)
  -  Any infectious toxic or mental condition preventing neoadjuvant therapy

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

Clinical trial: A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer

Summary: The purpose of this study is to determine the feasibility of chemotherapy, consisting of docetaxel, cisplatin and capecitabine given prior to surgery for stomach cancer. Furthermore, an extended type of removal of lymph nodes will be implemented.


Eligibility: Inclusion Criteria:
  -  Ib-IVa histological proven resectable gastric adenocarcinoma, including gastro-oesophageal junction/cardia carcinoma Siewert 2 and 3
  -  ASA 2 or less
  -  Age 18 years or more
  -  No prior radio- or chemotherapy conflicting with the treatment of gastric cancer
  -  Haematology/Renal function/Liver function within designated range
  -  Patient's consent form obtained, signed and dated before beginning specific protocol procedures
  -  absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  -  before patient registration/randomization, written informed consent must be given according to GCP, WMO and local regulations.
  Exclusion Criteria:
  -  Previous or other current malignancies, with the exception of adequately treated in situ carcinoma of the cervix uteri or non-melanoma skin cancer
  -  Other current serious illness or medical conditions
  -  Severe cardiac illness (NYHA class III-IV)
  -  Significant neurologic or psychiatric disorders
  -  Uncontrolled infections
  -  Active DIC
  -  Other serious underlying medical conditions that could impair the ability of the patient to participate in the study
  -  Known hypersensitivity to docetaxel (or any drug formulated with Polysorbate-80), or cisplatin or capecitabine or 5-FU
  -  Definite contraindications for the use of corticosteroids
  -  Use of immunosuppressive or antiviral drugs
  -  Any other experimental drugs within a 4-week period prior to start of neoadjuvant chemotherapy and throughout the study period
  -  Pregnant or lactating women
  -  Patients with reproductive potential not implementing adequate contraceptive measures

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

Clinical trial: Assess the Efficacy of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Gastric Cancer

Summary: The purpose of the study is to assess the efficacy and safety and PK of AZD8931 plus paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal junction, cancer.

Detailed description: A Phase IIa Multi-centre Randomised Double-Blind Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of AZD8931 in Combination with Paclitaxel versus Paclitaxel alone in Patients with Metastatic, Gastric or Gastro-oesophageal Junction, Cancer who progress following First Line Therapy and are Ineligible for Treatment with trastuzumab by HER2 Status (SAGE)

Eligibility: Inclusion Criteria:
  -  Male or female aged 18 years or older (20 years or older in Japan)
  -  Patients must have radiologically confirmed progression following 1st line fluoropyrimidine and platinum based treatment for metastatic gastric cancer (the date of progression and start of first line treatment to be captured on the database)
  -  Suitable for paclitaxel therapy.
  -  At least one lesion, not previously irradiated and not chosen for a mandatory fresh tumour biopsy during the study screening period, that can be accurately measured at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeat assessment.
  -  Ineligible for trastuzumab treatment by local assessment. This should include IHC analysis to determine HER2 status with further testing by FISH/CISH when considered part of local practice. Eligible patients are defined as; HER2 IHC 0, HER2 IHC +1 and +2
  Exclusion Criteria:
  -  Have received more than 1 prior chemotherapy regimen for metastatic gastric cancer. (chemotherapy as adjuvant treatment is permitted).
  -  Any prior taxane therapy (at any time from diagnosis of gastric cancer)
  -  Any prior therapy with an inhibitor of ErbB1 (EGFR) or ErbB2 (HER2) (eg, lapatinib)
  -  Resting ECG with measurable QTc(F) interval of greater than 480 msec at 2 or more time points within a 24 hour period (see section 6.4.9.1 )
  -  Unresolved toxicity grater than CTCAE grade 2 (except alopecia) from previous anti-cancer therapy

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

Clinical trial: A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer

Summary: This primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or HER2 overexpressing metastatic breast cancer or gastric cancer


Eligibility: Inclusion criteria:
  -  Patients with HER2+ breast cancer, or HER2+ gastric cancer, or squamous cell carcinoma of head and neck, or esophageal squamous cell carcinoma
  -  Site of disease that can be safely biopsied
  Exclusion criteria:
  -  Patients received prior anti-HER3 antibody treatment
  -  Patients with impaired cardiac function
  -  Brain metastases that have not been adequately treated
  -  Malignant disease other than that being treated in this study
  -  Pregnant or nursing (lactating) women
  -  Laboratory abnormalities as specified in the protocol 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: Nodal Status in Adenocarcinoma of the Esophagus an Cardia

Summary: Adenocarcinoma of the distal esophagus and cardia are grouped among the thoracic tumors according to the TNM 7th ed., however controversy is pending on the unique or dual pathogenesis (GERD or gastric-like cancerogenesis). It has been shown that biological patterns differ according to the presence (+) or absence (-) of Barrett's epithelium (BIM) and gastric intestinal metaplasia (GIM) in the fundus and antrum. Lymphatic metastatic spreading may differ according to the type of tumor. The investigators retrospectively investigated the pathways of lymphatic spreading in 194 consecutive patients who received radical surgery for adenocarcinoma of the esophagus and cardia with or without BIM and GIM.

Detailed description: The assumption that adenocarcinoma of the esophagus and cardia (ADEC) originates only from the sequence intestinal metaplasia followed by dysplasia and cancer is controversial. It has been shown that biological patterns differ according to the presence (+) absence (-) of Barrett's epithelium (BIM) and of gastric intestinal metaplasia (GIM) in the fundus and antrum. Lymphatic metastatic spreading may differ according to the type of tumor.
  Preoperatively patients underwent histological search for Barrett's esophagus (BIM) in mucosa surrounding (ADEC) and intestinal metaplasia in the gastric corpus and antrum mucosa (GIM). Patients in which BIM was documented underwent sub total esophagectomy and gastric pull up (group 1), others underwent esophagectomy at the azygos vein + total gastrectomy with Roux Y esophagojejunostomy (group 2). Radical lymphadenectomy was identical in both procedures except for the greater curvature station.

Eligibility: Inclusion Criteria:
  -  preoperative diagnosis of adenocarcinoma of the distal esophagus and cardia
  -  preoperative from local to locally advanced disease
  -  absence of neoadjuvant therapy
  Exclusion Criteria:
  -  neoadjuvant therapy
  -  metastatic disease
  -  unfit for surgery

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

Clinical trial: Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

Summary: This study evaluate whether treatment of Helicobacter pylori infection reduces the incidence of gastric cancer in subjects with family history of gastric cancer.

Detailed description: Helicobacter pylori infection is associated with gastric cancer in epidemiological studies. However, it is still unknown whether H. pylori eradication is useful and required to prevent gastric cancer.
  Gastric cancer risk is increased in family members of gastric cancer patient. Though there is no direct evidence that H. pylori infection is a risk factor for gastric cancer in family members of gastric cancer, current European guideline recommends H. pylori eradication in first-degree relatives of gastric cancer patients.
  In this study, the investigators will evaluate whether H. pylori eradication can reduce gastric cancer risk in the first-degree family members of gastric cancer patients.

Eligibility: Inclusion Criteria:
  -  Sibling or offspring of patients with gastric adenocarcinoma confirmed by EGD and biopsy
  -  Informed consent should be signed
  Exclusion Criteria:
  -  Gastric cancer history
  -  Other malignancy within the past 5 years
  -  Hereditary cancer family member (HNPCC, FAP)
  -  Peptic ulcer history
  -  Peptic ulcer, esophageal cancer, gastric cancer case found at EGD
  -  H. pylori eradication treatment history
  -  Previous serious side effect to antibiotics
  -  Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases
  -  Pregnant or nursing women
  -  Psychiatric disorder that would preclude compliance, alcoholics
  -  Refuse informed consent

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

Clinical trial: A Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab With Chemoradiotherapy in the Adjuvant Setting in Operated Participants With Human Epidermal Growth Factor Receptor-2 Positive (HER2+) Gastric or Gastroesophageal Junction Cancer

Summary: This single-arm, open-label study will evaluate the safety and efficacy of the combination oxaliplatin, capecitabine, and trastuzumab with chemoradiotherapy in the adjuvant setting in participants with curatively resected HER2+ gastric or gastroesophageal junction cancer. Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of Cycle 1 and 6 mg/kg IV on Day 1 of every following 3-week cycle, with oxaliplatin 100 milligrams per square meter (mg/m^2) IV on Day 1 of Cycles 1-3, and capecitabine 850 mg/m^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy. Radiotherapy will be given at a total dose of 45 gray (Gy) divided into 25 doses on 5 treatment days each week for 5 weeks starting Day 22 of Cycle 3. Anticipated time on study treatment is 1 year plus a 1-year follow-up period.


Eligibility: Inclusion Criteria:
  -  Curatively resected HER2+ gastric or gastroesophageal junction adenocarcinoma; HER2+ status as defined by immunohistochemistry-2 positive or 3 positive with corroborative Fluorescence In Situ Hybridization+ result
  -  Participants with stages between Stage IB (T1N1M0) and Stage IIIC
  -  ECOG performance status score equal to or less than (<=) 2 during screening
  -  Left ventricular ejection fraction equal to or higher than (>=) 55% with acceptable levels of liver and renal functions
  -  No known contraindication to capecitabine, oxaliplatin, and trastuzumab
  -  No contraindication for radiotherapy or has not received any previous radiotherapy to the gastric region for any reason
  Exclusion Criteria:
  -  Participants with a malign condition in the last 5 years except squamous cell carcinoma of the skin
  -  Previous neoadjuvant chemotherapy and/or radiotherapy
  -  Any disruption in the physical integrity of the upper gastrointestinal tract (except surgical intervention for gastric or gastroesophageal junction carcinoma)
  -  Known (previously diagnosed and ongoing) malabsorption syndrome
  -  Active gastrointestinal bleeding
  -  Participants with Stage IV gastric or gastroesophageal junction adenocarcinoma
  -  Clinically significant cardiac or cardiovascular disease
  -  Uncontrolled hypertension
  -  Participants who have received any investigational anti-cancer treatment or are being treated in a concomitant investigational drug study
  -  Abnormal laboratory values at screening for serum total bilirubin, alanine aminotransferase or aspartate amino transferase, alkaline phosphatase, absolute neutrophil count, platelet count, and/or hemoglobin
  -  Known or suspected hypersensitivity against trastuzumab or proteins of rodents
  -  Pregnancy or lactation

Relevance to patient case: possibly relevant