araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC)

Summary: For patients with advanced HCC not suitable for resection or liver transplantation but without extrahepatic manifestations, local therapy with TACE is regarded as standard treatment. The present study is planned to evaluate the combination of TACE and sorafenib. A combination of TACE with a multitarget inhibitor like sorafenib may further improve the outcome of patients with HCC.


Eligibility: Inclusion Criteria:
  -  with histologically confirmed HCC not suitable for resection or liver transplantation
  -  Patients with measurable disease according to RECIST
  -  Performance status ECOG 0-2
  -  Normal organ and bone marrow function (defined)
  -  Women of childbearing potential must have performed a negative serum pregnancy test
  -  male or female patients must use an approved contraceptive method during treatment and for 3 months after end of treatment after the end of treatment with study medication
  -  Written informed consent
  Exclusion Criteria:
  -  Patient is eligible for liver resection or liver transplantation
  -  Extrahepatic tumor manifestation
  -  Thrombosis of the portal vein
  -  > 8 points according to Child Pugh classification
  -  Prior TACE or RFTA or any other local ablative treatment
  -  Prior systemic anticancer chemotherapy or radiotherapy for HCC
  -  Total bilirubin > 4.5 mg/dl
  -  Life expectancy of less than 12 weeks
  -  Esophageal varices grade III without prophylactic band ligation
  -  Cardiac diseases (defined)
  -  Uncontrolled hypertension
  -  Known or suspected hyperthyroid state
  -  Known brain metastasis
  -  Patients with seizure disorder requiring medication
  -  History of organ allograft
  -  Active clinically serious infections > CTCAE grade 2
  -  Thrombotic or embolic events
  -  Hemorrhage/bleeding event (defined)
  -  Acute variceal bleeding
  -  Therapeutic anticoagulation with vitamin K antagonists (defined)
  -  Known or suspected allergies to sorafenib, doxorubicin or lipiodol or any agent given in the course of this trial
  -  Contraindications to the use of sorafenib, doxorubicin or lipiodol
  -  Previous cancer distinct in primary site or histology from HCC (defined)
  -  substance abuse
  -  Participation in another clinical trial with any investigational study drug
  -  Lactating women
  -  Incapability to give valid informed consent

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer

Summary: The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.

Detailed description: Cancer cachexia is a devastating, often late-stage complication of an underlying malignancy. Despite the significant importance of cancer-related cachexia, treatments are lacking and there are no products approved for this indication. Anamorelin HCl, by virtue of its ghrelin agonist activity, may serve a role in the treatment of cancer cachexia. This placebo controlled dose range study will evaluate the safety and efficacy of anamorelin HCl in patients with non-small cell lung cancer, a cancer associated with a high prevalence of cachexia.

Eligibility: Inclusion Criteria:
  -  stage IIIB or IV NSCLC
  -  eligible for treatment of NSCLC with paclitaxel and carboplatin +/- bevacizumab
  Exclusion Criteria:
  -  mixed large and small cell histologies for lung cancer
  -  significant obesity, BMI > 30

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer

Summary: This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers to identify objective response rate and to assess for early markers of activity and to assess correlative markers that may provide helpful information for subsequent clinical trials. Approximately 110 patients from 7 centers in Canada will be enrolled into this study.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed high grade serous and/or undifferentiated carcinoma of ovary, fallopian tube or peritoneum
  -  Oestrogen, progesterone and HER2 negative advanced adenocarcinoma of the breast
  -  Known BRCA positive breast cancer or ovarian cancer, that is not high grade serous or undifferentiated tubo-ovarian carcinoma.
  -  Performance status of no more than 2.
  Exclusion Criteria:
  -  Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry
  -  Major surgery with 4 weeks of entering the study and must have recovered from effects of any major surgery .

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: A Study of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin in Advanced Non Small Cell Lung Cancer

Summary: The purpose of this study is to determine whether Mycobacterium w in combination with Paclitaxel plus Cisplatin are effective in Advanced Non Small Cell Lung cancer.

Detailed description: Non-small cell lung cancer (NSCLC) accounts for 75% of all lung cancers. majority of patients of NSCLC patients are stage IIIA or IIIB patients are suitable for radiotherapy, which could not improve the survival rates of 5-10%. This study proposed Mycobacterium w (heat killed) in combination chemotherapy of Cisplatin and Paclitaxel along with radiotherapy for adjuvant therapy management of NSCLC in controlled clinical trial, which may prove the efficacy, better survival rate and quality of life.

Eligibility: Inclusion Criteria:
  -  Ability to understand and the willingness to sign a written informed consent document.
  -  Histologically or cytologically confirmed Non-Small Cell Cancer, Stage IIIB or IV.
  -  Age should be 18 years or above.
  -  ECOG should be in 0-1 range.
  -  Absolute neutrophil count ≥ 1,00,000/mm3
  -  hemoglobin ≥ 9.0g/dL
  -  AST and ALT ≤ 2.5 times upper limit of normal (ULN)range of institution (5times ULN if liver metastasis present).
  -  bilirubin not greater than 1.5 times ULN range of institution (3 times ULN if liver involvement).
  -  Creatinine ≤ upper limit of normal (ULN) range of institution.
  -  Negative pregnancy test for women of child bearing potential prior to entry into the trial.
  Exclusion Criteria:
  -  Patient who have cytotoxic chemotherapy or radiotherapy prior to entering the study
  -  Patient with systematic brain metastasis.
  -  History of allergic reaction attributed to paclitaxel, cisplatin or mycobacterium w or any of their ingredients.
  -  Pregnant women or nursing women.
  -  Uncontrolled intercurrent illness that would limit compliance with study requirements.
  -  HIV positive patients.
  -  Previous splenectomy.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Safety Study of Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies

Summary: In this study, MGCD265, a new anticancer drug under investigation, is given daily to patients with advanced malignancies to study its safety profile.

Detailed description: MGCD265 belongs to a new class of drugs with anticancer potential, known as tyrosine kinase inhibitors. MGCD265 was shown to slow down the growth of human cancer cells in mice. Clinical studies are being pursued to evaluate the safety of MGCD265 in cancer patients.
  In this study, MGCD265 is orally administered on a daily basis to patients with advanced malignancies.

Eligibility: Inclusion Criteria:
  -  Advanced metastatic or unresectable malignancy that is refractory to standard therapy and/or existing therapies are not likely to achieve clinical benefit, and/or the patient declines to receive standard treatment such as chemotherapy.
  -  Evaluable disease;
  -  Last dose of prior chemotherapy, radiation therapy, or investigational agents occurred at least 4 weeks before the start of therapy;
  -  Recovery from the adverse effects ≤ grade 1;
  -  Acceptable ECOG status 0, 1, or 2;
  -  Life expectancy greater than 3 months following study entry;
  -  Adequate laboratory values;
  -  For patients enrolling in the four expansion cohorts:
  -  NSCLC patients must meet criteria for MET and/or Axl expression or,
  -  HNSCC patients must meet criteria for MET and/or Axl expression or,
  -  NSCLC patients must meet criteria for amplification of the MET gene locus, defined MET mutations, or rearrangements involving the AXL or MET gene locus or;
  -  Patients with tumor types such as HNSCC, papillary renal carcinoma, gastric adenocarcinoma, and other solid tumors must meet criteria for amplification of the MET gene locus, defined MET mutations, or rearrangements involving the AXL or MET gene locus
  Exclusion Criteria:
  -  Uncontrolled concurrent illness;
  -  History of cardiovascular illness;
  -  QTc > 470 msec (including subjects on medication);
  -  Left ventricular ejection fraction (LVEF) < 50%;
  -  Immunocompromised subjects;
  -  History of bone marrow transplant;
  -  Lung tumor lesions with increased likelihood of bleeding;
  -  Symptomatic or uncontrolled brain metastases;
  -  Unable to swallow oral medications or with pre-existing gastrointestinal disorders.

Relevance to patient case: definitely relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Optical Coherence Tomography of the Airway for Lung Cancer or Lung Disease

Summary: RATIONALE: Diagnostic procedures, such as optical coherence tomography, may help find and diagnose lung cancer or precancerous cells.
  PURPOSE: This phase I trial is studying how well optical coherence tomography of the airway works in detecting abnormal cells in patients undergoing surgery for lung cancer or lung disease.

Detailed description: OBJECTIVES:
  -  Correlate optical coherence tomography images of the airway with airway histology.
  -  Develop an imaging technique to detect premalignant airway epithelial changes (carcinoma in situ, dysplasia) to study the transformation process as well as intervene and prevent the development of lung cancer.
  OUTLINE: Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery. All imaged areas are marked. The marked areas are then excised and fixed in formalin for histopathologic analysis.

Eligibility: DISEASE CHARACTERISTICS:
  -  Undergoing pneumonectomy or lobectomy for malignant or benign lung processes
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: A Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally Daily to Subjects With Solid Tumors

Summary: This clinical study is being conducted at two sites to determine the optimum dose, safety, and tolerability of oral daily GSK1363089 treatment in adults with solid tumors. This study is no longer recruiting subjects.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed solid tumor which is metastatic or unresectable with no known effective treatment measures,
  -  ECOG performance status of </= 2.
  -  Adequate bone marrow reserve, hepatic, renal, and cardiovascular function,
  -  Negative pregnancy test.
  Exclusion Criteria:
  -  Anticancer therapy within 30 days of the start of treatment,
  -  Received radiation to =25% of bone marrow within 30 days of treatment.
  -  Known brain metastasis,
  -  Uncontrolled intercurrent illness,
  -  HIV positive,
  -  Pregnant or breastfeeding women.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Zactima in Non Small Cell Lung Cancer (NSCLC) ELderly Patients In Combination With or Versus Gemcitabine

Summary: The primary objective of this study is to demonstrate an improvement in Progression-Free Survival (PFS) for the combination of vandetanib plus gemcitabine compared with gemcitabine plus placebo in chemonaïve (not including an adjuvant regimen) patients aged ≥ 70 years with advanced NSCLC.


Eligibility: Inclusion Criteria:
  -  Histologic or cytologic confirmation of advanced NSCLC (stage IIIB with supraclavicular lymph node metastases or pleural effusion or stage IV) on entry into study
  -  One or more measurable lesions at least 10 mm in the longest diameter (LD) by spiral CT scan or 20 mm with conventional techniques according to RECIST criteria
  -  Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3 months before the trial entry is accepted).
  -  Female or male aged 70 years or above
  Exclusion Criteria:
  -  Patients must not have received prior anti-cancer therapy except in the adjuvant setting
  -  Inadequate end-organ function or Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial
  -  Significant cardiovascular event (e.g. myocardial infarction, superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
  -  History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Retrospective Study Evaluating IGF1R And p95HER2 as Prognostic Factors in Non Small Cell Lung Cancer (NSCLC)

Summary: Aim of the study is to evaluated the role of IGF1R and p95HER2 on prognosis in radically resected non small cell lung cancer patients
  The primary objective is to correlate the expression of IGF1R and p95HER2 with survival.


Eligibility: Inclusion Criteria:
  -  Radically resected non small cell lung cancer patients with tumor tissue available
  Exclusion Criteria:
  -  Tumor tissue not available
  -  Clinical data not available

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Evaluation Of The Efficacy Of The Combination Of Axitinib With Pemetrexed And Cisplatin In The Treatment Of Non-Squamous Non-Small Cell Lung Cancer

Summary: AG-013736 (axitinib) in combination with cisplatin and pemetrexed will be evaluated as first-line treatment of patients with locally advanced, recurrent, or metastatic non-squamous, non small cell lung cancer (NSCLC).


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of adeno-, large cell or bronchioalveolar non-small cell lung cancer
  -  Cytologic specimens for diagnosis or for cell type classification must have been obtained from bronchial brushings or washings or from needle aspiration of a defined lesion. Sputum cytology alone will not be acceptable for diagnosis or for cell type classification.
  -  Patients with mixed NSCLC with predominantly squamous cell carcinoma should be classified as squamous and thus do not qualify for this study.
  -  Stage IIIB with malignant effusion (with cytologic confirmation of malignant pleural or pericardial effusion), Stage IV, or recurrent disease after definitive loco-regional therapy.
  -  Candidate for primary treatment with cisplatin and pemetrexed
  Exclusion Criteria:
  -  Any histological/cytological evidence of predominantly squamous NSCLC.
  -  Small cell or carcinoid lung cancer patients are also ineligible.
  -  NSCLC that cannot be classified as one of the eligible histologies (adenocarcinoma, large cell or bronchioalveolar).
  -  Prior systemic therapy for Stage IIIB (with malignant effusion), Stage IV, or recurrent NSCLC. (Prior treatment with systemic therapy as adjuvant chemotherapy or in conjunction with radiotherapy for Stage II or III NSCLC is permitted if the last dose of chemotherapy was completed 12 months or more prior to randomization).
  -  Prior treatment with a VEGF or VEGFR inhibitor.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: INSIGHT - Post Marketing Surveillance

Summary: In this international non-interventional post-marketing surveillance study we want to evaluate patient characteristics in HCC patients as well as efficacy and safety of Sorafenib (Nexavar®) treatment under daily-life treatment conditions. Specifically investigated are the tumor status, prior and/ or concomitant surgical, radiological and drug treatment and the duration of Sorafenib treatment.


Eligibility: Inclusion Criteria:
  -  In- and outpatients with diagnosis of hepatocellular carcinoma (HCC) and decision taken by the investigator to prescribe Nexavar
  Exclusion Criteria:
  -  Exclusion criteria must be read in conjunction with the local product information

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: AMG 386 Phase 2 Open-Label Renal Cell Carcinoma (RCC) Study 1st Line or After Cytokine Failure in Combination With Sunitinib

Summary: This phase 2 study is an open-label, multi-center study to determine the safety and tolerability of AMG 386 in combination with sunitinib in the treatment of subjects with metastatic renal cell carcinoma.


Eligibility: Inclusion Criteria:
  -  Subjects must have a histologically confirmed metastatic RCC with a clear cell component
  -  Low or intermediate risk according to the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk classification
  -  Measurable disease with at least one unidimensionally measurable lesion per RECIST guidelines with modifications
  -  Adequate organ and hematological function as evidenced by laboratory studies conducted at Screening
  -  ECOG of 0 or 1
  Exclusion Criteria:
  Disease related
  -  Known history of central nervous system metastases.
  -  Previous treatment (excluding surgery, prior cytokine-based immunotherapy and palliative radiotherapy) for advanced or metastatic renal cell carcinoma
  -  Focal radiation therapy for palliation of pain from bony metastases within 14 days of enrollment.
  Medications
  -  Currently or previously treated with sunitinib or other small molecule inhibitors of VEGF
  -  Currently or previously treated with agents that neutralizing VEGF
  -  Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor
  -  Currently or previously treated with agents inhibiting the mammalian target of rapamycin (mTOR)
  -  Current or within 30 days prior to enrollment treatment with immune modulators
  -  Concomitant or previous use within 30 days prior to enrollment of any strong inducer of CYP3A4
  -  Concomitant or previous use of amiodarone within 6 months prior to enrollment
  General medical
  -  Clinically significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
  -  Major surgery within 28 days prior to enrollment or still recovering from prior surgery
  -  Uncontrolled hypertension as defined as diastolic > 90 mmHg OR systolic >150 mmHg. The use of anti-hypertensive medications to control hypertension is permitted.
  Other
  -  Other investigational procedures are excluded
  -  Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)

Summary: This is a Phase II, double-blind, randomized, multicenter trial designed to preliminarily evaluate the activity and safety of treatment with MetMAb + erlotinib versus erlotinib + placebo in second- and third-line Non-Small Cell Lung Cancer (NSCLC). Up to 180 patients will be randomized in a 1:1 ratio to one of the two treatment arms.


Eligibility: Inclusion Criteria:
  Patients must meet the following criteria for study entry:
  -  Histologically confirmed NSCLC
  -  Availability of a tumor specimen
  -  Recurrent or progressive disease following at least one chemo containing regimen for Stage IIIB/IV disease
  -  Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
  -  At least one measurable lesion on a pre-treatment 18-fluorodeoxyglcose−positron emission tomography (FDG-PET) scan that is also a target lesion on computed tomography (CT) according to RECIST
  Exclusion Criteria:
  -  More than two prior treatments for Stage IIIB/IV
  -  More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known epidermal growth factor receptor (EGFR)-related toxicity resulting in dose modifications
  -  Chemotherapy, biologic therapy, radiotherapy or investigational drug within 28 days prior to randomization
  -  Untreated and/or active (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) central nervous system (CNS) metastasis
  -  History of serious systemic disease within the past 6 months prior to randomization
  -  Uncontrolled diabetes
  -  Major surgical procedure or significant traumatic injury within 28 days prior to randomization
  -  Anticipation of need for a major surgical procedure during the course of the study
  -  Local palliative radiotherapy within 7 days prior to randomization or persistent adverse effects from radiotherapy that have not been resolved to Grade II or less prior to randomization
  -  Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy

Relevance to patient case: definitely relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Analysis of Expression of Specific Markers in Hepatocellular Carcinoma

Summary: Hepatocellular carcinoma is an aggressive disease with limited therapeutic options. Therefore, new approaches to treat this type of cancer are needed with immunotherapy potentially being one of these. As a first step in the development of novel therapies, expression analysis of specific markers, including tumor antigens will be carried out. This will be done retrospectively using available hepatocellular carcinoma tissue samples.


Eligibility: Inclusion Criteria:
  -  The patient had pathologically proven hepatocellular carcinoma
  -  All the data required are available from patient's records
  -  A sufficient amount of RNA is available for all three tissue samples
  Exclusion Criteria:

Relevance to patient case: not relevant