araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: A Phase I Study of AZD1480 in Patients With Advanced Solid Malignancies and Advanced Hepatocellular Carcinoma in the Escalation Phase,Non-Small Cell Lung Cancer(NSCLC) and Non-smokers With Lung Metastasis and Gastric Cancer and Solid Tumour in the Expansion Phase.

Summary: This is Phase I, open-label and dose escalation study to evaluate the safety and tolerability of AZD1480(JAK2 inhibitor) in Asian patients with advanced solid tumors (Part A and C) and in patients with advanced HCC (Part B) in the escalation phase, EGFR or ROS mutant NSCLC and non-smokers with lung metastasis and gastric cancer in the expansion phase and to evaluate daily and BID dosing.


Eligibility: Inclusion Criteria:
  -  Male or female aged 18 years or older
  -  For Part A and C: Histological or cytological confirmation of a solid malignant tumour refractory to standard therapies or for which no standard therapies exist. Patients with lymphoma & HCC are excluded.
  -  For Expansion : Histological or cytological confirmation of
  -  Expansion 1: EGFR and/or ROS mutant NSCLC or Non-smokers with lung metastasis
  -  Expansion 2: Gastric cancer or solid tumour with biopsy available (consenting paired biopsies)refractory to standard therapies or for which no standard therapies exist. Patients with lymphoma & HCC are excluded.
  -  For Part B : Advanced or metastatic HCC, unresectable and incurable with ablative therapy or TACE, with no standard therapy available.
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with no deterioration over the previous 2 weeks
  -  For Part B : Child-Pugh liver function status classified as A to B7
  Exclusion Criteria:
  -  For any other chemotherapy, immunotherapy or anticancer agents, within 5 half lives or 3 weeks must have elapsed from treatment to of the first dose of investigational product, whichever is shorter.
  -  With the exception of alopecia, any unresolved toxicities from prior therapy ≥ Grade 2 of CTCAE V4.02 at the time of starting study (except LFTs for HCC patients, which may be Grade 2 at the time of starting the study)
  -  Any of the following conditions:Interferon treatment for HBV and HCV Prior Liver Transplantation
  -  Inadequate bone marrow reserve or organ function as demonstrated by laboratory values
  -  Evidence of established interstitial lung disease(ILD) on baseline high resolution computerized tomography(HRCT)

Relevance to patient case: possibly relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Effect of Weight Loss on Breast Density Using Digital Mammography and MRI in Women Who Are At Increased Risk For Breast Cancer

Summary: Diagnostic procedures, such as digital mammography and MRI, may help measure how weight loss affects breast density in women who are at increased risk for breast cancer.

Detailed description: OBJECTIVES: I. To determine if weight loss in patients undergoing Roux en Y gastric bypass procedures has any effect on breast density as measured by mammography and breast MRI. OUTLINE: GROUP I: Participants undergo mammography and MRI at baseline and 1 year. Participants also undergo gastric bypass surgery. GROUP II: Participants undergo mammography and MRI at baseline and 1 year. After completion of study treatment, patients are followed up at 1 year.

Eligibility: Inclusion Criteria:
  -  Women eligible for gastric bypass surgery
  -  Pre-menopausal women
  -  All women will have signed an informed consent form prior to participating in study procedures
  Exclusion Criteria:
  -  Women with a history of breast cancer
  -  Women currently taking exogenous hormone replacement therapy
  -  Women currently taking a SERM
  -  Women currently taking an aromatase inhibitor
  -  Pregnant or lactating women
  -  Women who have been pregnant or lactating in the past 2 years
  -  Women who have metallic or other surgical implants
  -  All subjects will have a determination of their estimated glomerular filtration rate (eGFR) within 24 hours of undergoing any study where gadolinium based contrast agents will be administered
  -  Subjects should not have a known history of recent onset acute renal dysfunction
  -  Subjects with a history of stable chronic renal dysfunction may participate in studies using GBCA based on their eGFR, as outlined below
  -  Subjects should not have severe liver dysfunction, particularly when associated with kidney disease
  -  Subjects should receive GBCAs in the perioperative period (i.e. within 4 weeks) after renal or liver transplantation

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients

Summary: A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.


Eligibility: Inclusion Criteria:
  -  Patients meeting the Rome III Diagnostic Criteria
  -  Loose (mushy) or watery stools within the last 3 months
  -  Abdominal discomfort and/or pain during their non-menstrual period
  Exclusion Criteria:
  -  Patients with a history of surgical resection of the stomach, small intestine or large intestine
  -  Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
  -  Patients with a history or current diagnosis of colitis ischemic
  -  Patients with a current diagnosis of enteritis infectious
  -  Patients with a current diagnosis of hyperthyroidism or hypothyroidism
  -  Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study
  -  Patients with a history or current diagnosis of malignant tumor
  -  Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations

Summary: This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m^2 intravenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m^2 iv on Day 1.


Eligibility: Inclusion Criteria:
  -  Adult participants, ≥ 18 years of age.
  -  Locally advanced or recurrent (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
  -  Presence of epidermal growth factor receptor (EGFR) mutations in tumours.
  -  Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria.
  -  European Cooperative Oncology Group (ECOG) performance status ≤ 2.
  Exclusion Criteria:
  -  Prior exposure to agents directed at the human epidermal receptor (HER) axis (eg, but not limited to erlotinib, gefitinib, cetuximab, or trastuzumab).
  -  Prior chemotherapy or systemic anti-neoplastic therapy for advanced disease.
  -  Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or active gastroduodenal ulcer disease.
  -  Any inflammatory changes of the surface of the eye.
  -  ≥ Grade 2 peripheral neuropathy.
  -  History of any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer.
  -  Brain metastasis or spinal cord compression that has not yet been definitely treated with surgery and/or radiation, or treated but without evidence of stable disease for at least 2 months.
  -  Human immunodeficiency virus (HIV) infection.
  -  Pregnant, nursing, or lactating women.

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

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: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRIGGER)

Summary: This single-arm, open-label study will evaluate the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer. Patients will receive daily oral doses of 150 mg Tarceva. The anticipated time on study treatment is 12 months.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/=18 years of age
  -  Locally advanced or metastatic non-small cell lung cancer
  -  Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  -  Life expectancy over >/=12 weeks
  -  Adequate hematological, liver, or kidney function
  Exclusion Criteria:
  -  Previous therapy against epidermal growth factor receptor for metastatic disease
  -  Treatment with investigational drug during the 3 weeks before enrollment
  -  History of neoplasm
  -  Patients with symptomatic cerebral metastases
  -  Unstable systemic disease

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer

Summary: The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.

Detailed description: A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE study). Patients were to be assigned to strata by FGFR2 status of: polysomy, low or high gene amplification.

Eligibility: Inclusion Criteria:
  -  Female or male aged 25 or over
  -  Histological diagnosis of locally advanced or metastatic gastro adenocarcinoma (including adenocarcinoma of the lower third of the oesophagus or the gastro oesophageal junction )
  -  Radiographically confirmed progression after 1 prior chemotherapy or chemoradiotherapy for gastric cancer. Suitable for and expected to benefit from paclitaxel monotherapy.
  -  At least one lesion, not previously irradiated, that has baseline at least 10mm in the longest diameter for non nodal lesions and is assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI)
  -  Provision of either an archival tumour sample or a fresh tumour sample for confirmation of FGFR2 polysomy/gene amplification
  Exclusion Criteria:
  -  Prior exposure to AZD4547 or history of hypersensitivity other drugs similar in structure or class to AZD4547. Hypersensitivity to paclitaxel or formulated in cremophor EL (polyoxyethylated castor oil)
  -  Prior taxane treatment for gastric cancer with the exception of adjuvant/neo-adjuvant therapy given > 6 months; Major surgery, radiotherapy with wide field of radiation or any cancer treatment within 4 weeks before the first dose of the study treatment
  -  With the exception of alopecia, any unresolved toxicities from prior therapy with a Common Terminology Criteria for AE (CTCAE) grade >1 at the time of starting study treatment.
  -  Blood and Echocardiogram (ECG) readings that are deemed to be abnormal by falling outside of the reference ranges in the protocol inclusion/exclusion section.
  -  Taking other regular medication that are predicted to interact with AZD4547 due to their route of metabolism.

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: An Evaluation of the Biodistribution and Imaging Characteristics of ABT-806i (111In-ABT-806) in Subjects With Advanced Solid Tumor Types

Summary: This is an open label study designed to evaluate the biodistribution and imaging characteristics of ABT-806i (111In-ABT-806) in subjects with advanced solid tumor types.


Eligibility: Inclusion Criteria:
  -  Subject has a solid tumor of a type likely or known to either overexpress wild-type Epidermal Growth Factor Receptor (EGFR) or to express variant III mutant EGFR (e.g., head and neck squamous cell carcinoma, Non-small Cell Lung Carcinoma (NSCLC), and colorectal carcinoma).
  -  Subject must have disease that is not amenable to surgical resection or other approved therapeutic options with curative intent.
  -  Subject cannot tolerate or must not be eligible for other approved therapeutic options with known survival advantage.
  -  Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  -  Subject must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 with at least 1 extrahepatic 2 cm lesion.
  Exclusion Criteria:
  -  Subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 14 days prior to the first dose of ABT-806i.
  -  Subject has received a prior EGFR-directed monoclonal antibody within a period of 4 weeks prior to the first dose of ABT-806i.
  -  Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
  -  Subject has had major surgery within 21 days prior to the first dose of ABT-806i.
  -  Subject has a clinically significant uncontrolled condition(s) including but not limited to the following:
  -  Active uncontrolled infection
  -  Symptomatic congestive heart failure
  -  Unstable angina pectoris or cardiac arrhythmia
  -  Psychiatric illness/social situation that would limit compliance with the study requirements

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: a Prospective Study on the Efficacy of Magnifying Endoscopy With Narrow-band Imaging in Diagnosing Gastric Lesions

Summary: Magnifying endoscopy with narrow-band imaging (ME-NBI) can emphasize surface pattern and microvascular architecture of the gastric mucosa.However,the usefulness and criteria of NBI for differential diagnosis among early gastric cancers (EGC) have not been fully established.The study is based on the hypothesis:
  1. ME-NBI is useful in distinguishing EGC from other gastric lesions
  2. ME-NBI is useful in further differential diagnosis among EGCs.


Eligibility: Inclusion Criteria:
  -  patients with gastric lesions which were detected by conventional screening endoscopy and suspected of early malignancy.
  Exclusion Criteria:
  -  advanced gastric cancer or any other malignancy;
  -  patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc;
  -  inability to provide informed consent;
  -  inability to provide histology of resected specimens after endoscopic treatment or surgery.

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Helicobacter Pylori Eradication After Endoscopic Resection of Gastric Tumors

Summary: The purpose of this study is to determine whether Helicobacter pylori eradication could reduce the new tumor development after endoscopic resection of gastric tumor.

Detailed description: The association between Helicobacter pylori infection and development of gastric cancer has been established by epidemiologic studies. Conversely, eradication of H. pylori showed no significant reduction of the incidence of gastric cancer in a large-scale, double-blind, randomized controlled trial. Eradication of H. pylori to prevent cancer was only effective in the subgroup without precancerous lesions (i,e, dysplasia, intestinal metaplasia, and atrophy). In contrast, randomized prospective study in Japan showed that H. pylori eradication after endoscopic resection of early gastric cancer significantly reduced metachronous gastric cancer. To solve this conflicting issue is critical because gastric cancer is the second leading cancer incidence worldwide, particularly Korea, Japan, and China have highest cancer incidence, and its incidence might decrease by H. pylori eradication treatment.
  With respect to therapeutic modality, endoscopic resection for early gastric cancer is currently the established treatment of choice in Korea and Japan because it has been proven to be both minimally invasive and effective in the curative treatment of early gastric cancer.
  Endoscopic resection has also been performed in the gastric dysplasia because dysplasia has to some extent malignant potential although firm evidence is lacking. In comparison with surgical resection, endoscopic resection conserves remnant stomach. Accordingly, patients treated with endoscopic resection have higher possibility for metachronous gastric cancer than those treated with surgical resection.
  So far, it has not yet been clearly established whether H pylori eradication for gastric tumors (early gastric cancer and gastric dysplasia) could reduce metachronous cancer. We performed randomized controlled, open-label trial on the effect of new cancer development after H pylori eradication for gastric tumors.

Eligibility: Inclusion Criteria:
  -  H pylori infected patients with gastric low-grade dysplasia, high-grade dysplasia, and early gastric cancer
  -  Gastric tumor is completely removed through endoscopic resection.
  Exclusion Criteria:
  -  Patients underwent gastrectomy before enrollment
  -  patients underwent endoscopic resection before enrollment
  -  Previous history of eradication for H. pylori
  -  Pregnancy
  -  Aged <20 yr old or aged >75 yr old
  -  Patients underwent additional gastrectomy due to incomplete endoscopic resection

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

Summary: Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival or overall survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.


Eligibility: Inclusion Criteria:
  -  ≥ 18 and ≤ 70 years of age
  -  Histological confirmed advanced or metastatic adenocarcinoma of the stomach
  -  Have failed for at least 2 lines of chemotherapy
  -  Life expectancy of at least 12 weeks.
  -  Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 1 week before randomization.
  -  At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral CT scan)
  -  Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
  -  More than 4 weeks for operation or radiotherapy
  -  More than 4 weeks for cytotoxic agents or growth inhibitors
  -  Adequate hepatic, renal, heart, and hematologic functions (HB ≥ 90g/L,platelets > 80 ×10 E+9/L, neutrophil > 1.5 × 10 E+9/L, serum creatinine ≤ 1× upper limit of normal(ULN), bilirubin < 1.25× ULN, and serum transaminase ≤ 2.5× ULN).
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg).
  -  Any factors that influence the usage of oral administration; Evidence of Central Nerves System(CNS) metastasis
  -  Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure and proteinuria ≥ (+)
  -  International Normalize Ratio (INR) > 1.5 and activated partial thromboplastin time（APPT） > 1.5 × ULN
  -  Abuse of alcohol or drugs
  -  Certain possibility of gastric or intestine hemorrhage
  -  Less than 4 weeks from the last clinical trial
  -  Prior VEGFR inhibitor treatment
  -  Disability of serious uncontrolled intercurrence infection Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc.

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Qualitative Research for Stage 4 Stomach Cancer and Their Caregivers

Summary: Find A Cure Panel is looking for people with Stage 4 stomach/gastric cancer or the caregivers of people with Stage 4 stomach/gastric cancer to participate in anonymous and qualitative research that will take an estimated 60 minutes of your time.
  This is opinion based, experiential research and is NOT a drug trial.
  Note that Stage IV is also known as "advance disease" or metastatic stomach/gastric cancer.
  If you are interested in participating, please email FACP at: info@findacurepanel.com


Eligibility: Inclusion Criteria:stage 4 stomach cancer patients and caregivers -
  Exclusion Criteria:loved one must still be living

Relevance to patient case: not relevant