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

Clinical trial: The Study of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric Cancer

Summary: The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib as the third line therapy for patients with advanced gastric cancer.

Detailed description: 400 patients with stage Ⅳ Gastric Cancer,who had received surgery and chemotherapy,will be randomly divided into group A（receive Apatinib and CIK treatment ) or group B（just receive Apatinib),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only Apatinib (continuous) .

Eligibility: Inclusion Criteria:
  -  Patients who can accept curative operations 18-70 years old
  -  Histologically confirmed with gastric cancer at stage Ⅳ
  -  Patients who can accept oral drugs;
  -  Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.
  Exclusion Criteria:
  -  Hemoglobin＜8.0 g/dL,White blood cell ＜3 X 10^9/L;Platelet count ＜75 X 10^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
  -  Known or suspected allergy to the investigational agent or any agent given in association with this trial
  -  Pregnant or lactating patients
  -  Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
  -  Patients who are suffering from serious autoimmune disease
  -  Patients who had used long time or are using immunosuppressant
  -  Patients who had active infection
  -  Patients who are suffering from serious organ dysfunction
  -  Patients who are suffering from other cancer
  -  Other situations that the researchers considered unsuitable for this study.

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

Clinical trial: Human Epidermal Growth Factor Receptor 2 (HER2) Advanced Gastric Epidemiology Study in Korea

Summary: This study is designed to gather epidemiological data in Korea on HER2 incidence in gastric and gastroesophageal junction cancer as assessed by local laboratories in a real-life setting. No investigational products will be provided or evaluated.


Eligibility: Inclusion Criteria:
  -  Formalin-fixed, paraffin-embedded tumor tissue samples with histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with locally advanced, recurrent, and/or metastatic disease
  -  Sufficient invasive tumor tissue for HER2 evaluation, including surgical excision specimens or at least 6 to 8 available biopsies
  Exclusion Criteria:
  -  None specified

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

Clinical trial: Weekly Use First-generation EGFR-TKI in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)

Summary: EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small cell lung cancer with EGFR gene mutation. The median progression free survival time is around 11 months with the first generation EGFR-TKI. Patients with acquired resistance with first generation EGFR-TKI usually with EGFR exon 20 mutation (T790M). Change the drug administration maybe prolong patients PFS and evently prolong OS.

Detailed description: 1st generation EGFR-TKI has reversible binding to EGFR, it also bind to T790M in a high dose which is account about 60% patients acquired resistance to the drug. Resistance patients may be benefit to a bolus drug use to block T790M gene.

Eligibility: Inclusion Criteria:
  -  NSCLC with EGFR mutation progressed after first generation EGFR-TKI, or progressed after chemotherapy and 1st generation EGFR-TKI or progressed after 1st generation EGFR-TKI and chemotherapy. Expected survival more than 3 months with a ECOG ≤3.
  Exclusion Criteria:
  -  liver function (ALT, AST) and renal function 2 times higher than normal limit; IPD; uncontrolled diarrhea; severe anemia.

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

Clinical trial: Comparison of Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy

Summary: The aim of this study is to show better postoperative quality of life including lower incidence of dumping syndrome and comparable survival after laparoscopic pylorus preserving gastrectomy (LPPG), compared to laparoscopic distal gastrectomy (LDG) in patients with middle-third early gastric cancer

Detailed description: Participating Surgeons
  Prior to this clinical trial, only the surgeons who are considered to have the standardization by review committee participated.
  Patients Registration
  It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.
  After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Seoul National University Hospital Medical Research Collaborating Center.
  Each group 128 patients, total 256 subjects will be enrolled.
  Randomization
  The registration randomization should be done with 1:1 ratio for each researcher.
  Baseline number (BN) should be provided to the subjects in the order of acquisition of informed consent form. Based on the subjects who are selected as the appropriate subjects in the end, the allocation number (AN) shall be provided in the order of randomized allocation table.
  Procedure
  Operations are performed according to the allocated group.

Eligibility: Inclusion Criteria:
  Patients are included in the trial if they meet all of the following criteria:
  -  histologically proven primary gastric adenocarcinoma
  -  aged 20-80 years old
  -  performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
  -  performance status (PS) of I to III on American Society of Anesthesiologists (ASA) score
  -  clinical stage T1N0M0, which are assessed by endoscopic ultrasound or computed tomography (CT) scan (AJCC 7th classification)
  -  location of primary tumor; middle third of stomach (more than 5cm away from the pylorus)
  -  written signed informed consent
  Exclusion Criteria:
  Patients are excluded if they meet any of the following criteria:
  -  pyloric deformity because peptic ulcer disease
  -  previous gastric surgery (e.g. gastro-jejunostomy, primary closure)
  -  synchronous lesion of early gastric cancer or adenoma in antrum
  -  prior treatment of endoscopic submucosal dissection, chemotherapy or radiation therapy against any other malignancies
  -  patients who need combined resection (eg. cholecystectomy)
  -  vulnerable patients (lack of decision-making capacity, pregnant, or breast-feeding women)
  -  participated in another clinical trial within the last six months or currently involved patients

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

Clinical trial: A Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors

Summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in selected advanced gastrointestinal and genitourinary tumors.


Eligibility: Inclusion Criteria:
  -  RCC (clear cell), urothelial carcinoma (transitional cell), gastric or gastro-esophageal junctional (GEJ) adenocarcinoma, or K-RAS or N-RAS wild-type EGFR expressing CRC
  -  For RCC:
  -  previously received at least 1 but no more than 4 lines of therapy, one therapy must have included a VEGF TKI
  -  ECOG performance status of 0-1 (score of 2 may be acceptable)
  -  For urothelial carcinoma:
  -  previously received at least 1 but no more than 2 lines of therapy, one therapy must have included a platinum based regimen
  -  ECOG performance status of 0-1
  -  For gastric or GEJ adenocarcinoma:
  -  previously received at least 1 but no more than 3 lines of therapy, one therapy must have included a fluoropyrimidine based regimen
  -  ECOG performance status of 0-1
  -  For CRC:
  -  previously received at least 2 but no more than 4 lines of therapy, which must have included both an irinotecan and an oxaliplatin based regimen
  -  ECOG performance status of 0-1 (score of 2 may be acceptable)
  -  For all cohorts:
  -  Adequate hematologic function:
  -  Absolute neutrophil count (ANC) >1500 cells/mm3
  -  For RCC, platelet count ≥80,000 cells/mm3
  -  For urothelial carcinoma, gastric or GEJ adenocarcinoma, and CRC, platelet count ≥100,000 cells/mm3
  -  For RCC, urothelial carcinoma, and gastric or GEJ adenocarcinoma, hemoglobin ≥8.0 g/dL
  -  For CRC, hemoglobin ≥9.0 g/dL
  -  Adequate hepatic and renal function defined as:
  -  AST and/or ALT ≤5.0 x upper limit of normal (ULN) if liver metastases, or ≤3 x ULN without liver metastases
  -  Alkaline phosphatase <3.0 x ULN or ≤5.0 x ULN if liver or bone metastases present
  -  Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)
  -  Estimated Creatinine Clearance ≥30 mL/min
  Exclusion Criteria:
  -  For RCC, prior treatment with everolimus or temsirolimus
  -  For urothelial carcinoma, prior treatment with any taxane
  -  For gastric or GEJ adenocarcinoma, prior treatment with any taxane
  -  For CRC, prior treatment with cetuximab or panitumumab
  -  For all cohorts:
  -  concomitant use of warfarin or other Vitamin K antagonists
  -  history of stroke or intracranial hemorrhage within 6 months prior to enrollment
  -  major surgery within 4 weeks of first dose of study drug
  -  requires treatment with strong CYP3A inhibitors
  -  known bleeding disorders or hemophilia

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

Clinical trial: Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes

Summary: This trial is conducted globally. The aim of the trial is to investigate efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes.


Eligibility: Inclusion Criteria:
  -  Male or female, age at least 18 years at the time of signing informed consent For Japan only: Male or female, age at least 20 years at the time of signing informed consent
  -  Diagnosed with T2DM (type 2 diabetes mellitus) for at least 90 days prior to day of screening
  -  HbA1c (glycosylated haemoglobin) 7.0-10.5 % (53-91 mmol/mol) (both inclusive).
  -  Stable daily dose of metformin (equal or above 1500 mg or maximum tolerated dose as documented in subject medical record) alone or in combination with SU (= half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) within 90 days prior to the day of screening
  Exclusion Criteria:
  -  Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).For certain specific countries: Additional specific requirements apply
  -  Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC)
  -  History of pancreatitis (acute or chronic)
  -  History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
  -  Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack within the past 180 days prior to the day of screening
  -  Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
  -  Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
  -  Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
  -  History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)

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

Clinical trial: Diagnosis of Gastric Precancerous Lesions by a Blood Test GastroPanel in Patients With Increased Gastric Cancer Risk

Summary: Despite the declining incidence, gastric cancer (GC) remains the second leading cause of cancer death worldwide. In France, it is the second digestive cancer with 7,000 new cases per year. It is now well demonstrated that patients with H. pylori infection, atrophic gastritis and intestinal metaplasia, have a high risk of developing GC. It is therefore important to detect these pre-neoplastic lesions at an early stage to improve patients prognosis.
  Thus, the aim of this project is to investigate the possible screening of gastric precancerous lesions by a blood test (GastroPanel®) in France, in patients with oesophagogastroduodenoscopy (EGD) prescription.


Eligibility: Inclusion Criteria:
  -  Patients undergoing oesophagogastroduodenoscopy (EGD) according to usual care
  -  Patients with increased risk of gastric cancer (at least one of the following criteria):
  -  age > 50 years,
  -  family cases of gastric cancer,
  -  known precancerous lesions,
  -  Biermer disease,
  -  H. Pylori infection,
  -  genetic predisposition (ex: Lynch syndrome),
  -  MALT lymphoma,
  -  dyspepsia.
  -  Subjects affiliated with an appropriate social security system
  Exclusion Criteria:
  -  Subjects with known active cancer
  -  Pregnancy
  -  Patients receiving proton-pump inhibitors
  -  Conditions that may interfere with the study objectives according to the investigator

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

Clinical trial: EGFR Mutation Detection From Advanced NSCLC Patient Tissue and Plasma in EGFR-TKI Treatment

Summary: This study has been designed in order to detect EGFR mutation abundance of tissue and concentration of plasma from Advanced Non-small Cell Lung Cancer during treatment with Tyrosine Kinase Inhibitor (TKI) .Through this experiment the investigators aim to evaluate the feasibility of plasma EGFR detection and evaluate the correlation of EGFR mutations and prognosis.


Eligibility: Inclusion Criteria:
  -  Age older than 18 years and under 75 years
  -  Histologically and cytologically proven non-small Cell Lung Cancer
  -  Clinical stages Ⅲ ~ Ⅳ
  -  Not receive any anti-tumor treatment
  -  Eastern cooperative oncology group performance status (ECOG PS) =1~2
  -  Estimated survival time more than 3 months
  -  EGFR-TKI treatment for first-line or second-line
  -  Voluntary to participate in this clinical trial and sign the consent form
  Exclusion Criteria:
  -  Patients have received EGFR-TKI therapy before the study
  -  With other malignancy history in the recent 5 years before the study
  -  Pregnancy or breast feeding phase
  -  Inadequate samples for testing
  -  Follow-up compliance is poor

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

Clinical trial: Postoperative Enteral Immunonutrition in Gastric Cancer

Summary: Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival.
  The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.
  The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 (Reconvan ,Fresenius Kabi), or standard enteral nutrition n=54 (Peptisorb, Nutricia). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.

Detailed description: Treatment of gastric cancer often requires major surgery and carries the risk of postoperative complications and fatal outcomes. Mortality rates after gastrectomy due to gastric cancer have been reported as 2-5%, while the incidence of postoperative complications was 10 to over 40%.
  Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival.
  The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.
  The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 or standard enteral nutrition n=54. Following the initial randomization, the patients received either standard nutrition (oligopeptide, low-fat, isocaloric, non-residue diet - Peptisorb, Nutricia) or immunomodulating nutrition (protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.

Eligibility: Inclusion Criteria:
  -  gastric cancer confirmed in histopathological examination
  -  elective operation due to gastric cancer
  -  informed consent signed
  -  age > 18 years
  -  normal nutritional status or mild to moderate malnutrition
  Exclusion Criteria:
  -  severe malnutrition which required parenteral nutrition
  -  urgent operation

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

Clinical trial: Serological Screening of Gastric Cancer in Wuxi Region

Summary: The purpose of this study is to determine whether detection of pepsinogen Ⅰand Ⅱ combined with Helicobacter pylori antibody, so-called ABC method , is fit on gastric cancer screening in community of Wuxi City.

Detailed description: Gastric cancer is the third largest cause of cancer related deaths in China with about 350 ,000 gastric cancer-related deaths by gastric cancer in 2012. The studies from Japan and Korea have found gastric cancer screening, especially of the mass population, reduces mortality from gastric cancer, but the data is seldom in China. The ways include radiographic and endoscopic screening, although those methods were shown to reduce gastric cancer mortality, and was recommended as gold standard for population-based screening by Japan and Korea, but many problems have been pointed out: A serious drawback is low uptake of the target population; fear for radiation exposure(0.6 mSv), swallowing unpleasantness due to the use of barium meal, accidental fall during the examination and constipation, causing rare but more serious complications such as intestinal obstruction or diverticulitis after examination may account for the reasons for this low uptake, endoscopic screening is labor-intensive, more costly per examination as complete disinfection of the scope is mandatory, and requires a large number of well-trained experienced endoscopists.
  Serological method, so-called ABC method , has been useful as gastric cancer preliminary screening in some areas, such as China, Japan and Korea. The major reasons are attributed to its simplicity, safety (radiation-free, discomfort free), and cost-efficiency. The ABC method is a blood test to stratify the risk of gastric cancer using the combination of H. pylori antibody and pepsinogen I and II, that was documented by large-scale studies in Japan. But the data was short in China, especially in the community.

Eligibility: Inclusion Criteria:
  Age 40-70 years old, men and women are not limited, and there are one of the following:
  1. Hp infected.
  2. Previously suffering from chronic atrophic gastritis, gastric ulcer, gastric polyps, hypertrophic gastritis, pernicious anemia and other precancerous diseases of the stomach.
  3. First degree relatives of patients with gastric cancer.
  4. Other risk factors for gastric cancer. (high salt, salted diet, smoking, heavy drinking, etc.)
  Exclusion Criteria:
  1. Severe heart, liver, kidney, dysfunction or mental disorders
  2. History of gastric surgery (including surgery, minimally invasive EMR, ESD)
  3. Use of PPI, acid preparation, stomach protecting agent in the first two weeks
  4. The researchers considered inappropriate participants.
  5. Informed consent cannot be attained

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

Clinical trial: An Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer

Summary: This is an Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer, the investigators opted to give patients for apatinib 850 mg once daily, 28 days for a cycle. To evaluate the safety and efficacy of apatinib for Advanced Metastatic Gastric Cancer in the real world.

Detailed description: In the last decade, front-line chemotherapy has been considered a standard therapeutic regimen for the extension of survival time in patients with metastatic gastric cancer (mGC). New evidence suggests that salvage chemo-therapies, as second-line treatments, may have a survival advantage when compared with best supportive care. After failure of second-line chemotherapy, the results of further treatment are poor, yielding response rates of 0% to 5% with no evidence of prolonged survival. Apatinib is a small-molecule VEGFR-2 tyrosine kinase inhibitor, Had been approved by the CFDA for the treatment of advanced gastric cancer, However, this study defines a variety of inclusion/exclusion criteria, efficacy and safety are not well reflect in the real world for the treatment of advanced gastric cancer. Therefore, an Open Label, Prospective, Multicentre, Non-interventional Study could evaluate the safety and efficacy of apatinib for Advanced Metastatic Gastric Cancer in the real world.

Eligibility: Inclusion Criteria:
  -  》18 years old
  -  Advanced Metastatic Gastric Cancer
  -  The doctor evaluate that patients had benefit from treatment
  -  The patients signed the written informed consent
  Exclusion Criteria:
  -  Apatinib has been confirmed for allergy sufferers
  -  Pregnant or lactating women
  -  Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction)
  -  Doctors think doesn't inclusion

Relevance to patient case: definitely relevant