araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Mucosal Microbiome in Human Gastric Intestinal Metaplasia and Duodenal Tissue.

Summary: To investigate the mucosal microbiome in human gastric intestinal etaplasia and duodenal tissue.


Eligibility: Inclusion Criteria:
  -  Patients scheduled for gastroendoscopy examination Aged between 18 and 80 years old
  Exclusion Criteria:
  -  Antibiotic, probiotic or prebiotic usage within 2months,gastric inhibitor usage within 1 month Esophageal, gastric or duodenal cancer or other malignancy History of upper GI tract surgery Coagulopathy or bleeding disorders Allergy to fluorescein sodium Pregnant or breast-feeding (for females) Impaired renal function

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Irreversible Electroporation(IRE) For Unresectable Stomach Neoplasms

Summary: The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Stomach Neoplasms.

Detailed description: By enrolling patients with unresectable Head and Stomach adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Stomach Neoplasms.

Eligibility: Inclusion Criteria:
  -  Stomach Neoplasms diagnosed by positive biopsy or non-invasive criteria,
  -  Not suitable for surgical resection,
  -  Eastern Cooperative Oncology Group (ECOG) score of 0-1,
  -  A prothrombin time ratio > 50%,
  -  Platelet count > 80x10^9/L,
  -  Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
  -  Able to comprehend and willing to sign the written informed consent form (ICF),
  -  Have a life expectancy of at least 3 months.
  Exclusion Criteria:
  -  Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
  -  Any active implanted device (eg Pacemaker),
  -  Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
  -  Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
  -  Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: The Expression of ZEB1 in CTCs Associated With Metastasis and Recurrence for Gastric Cancer

Summary: The aim of this study was to investigate the expression of ZEB1 in CTCs for gastric cancer, its correlation with the clinicopathology of gastric cancer, and the role of ZEB1 in invasion and metastasis in gastric cancer.

Detailed description: Invasion and metastasis of tumors and postoperative recurrence are the main causes of death in patients with gastric cancer and are also the key factors affecting the clinical treatment and prognosis.
  In this study, the investigators will detect the expression of ZEB1 in different types of CTCs(epithelial,mesenchymal and mixed phenotype) for gastric cancer by CanPatrolTM2 detection technology.Our investigation of the relationship between ZEB1 and the occurrence and development as well as the invasion and metastasis of gastric cancer is expected to provide data for the prognosis and targeted therapy of gastric cancer.
  Approximate 100 consecutive patients with gastric cancer and CTCs(+) will be enrolled in this study.Detection of ZEB1 expression in CTCs at baseline will show the relationship between ZEB1 and clinicopathological variables. Postoperative follow-up of ZEB1 expression in CTCs will be performed every three months in the first year and every six months in the following two years. The results may indicate the role of ZEB1 in CTCs about invasion and metastasis for gastric cancer .The aim of this study is to clarify the clinical significance of ZEB1 expression in CTCs for gastric cancer.

Eligibility: Inclusion Criteria:
  1. Pathologically proven gastric cancer and CTCs(+).
  2. Age:older than 18 years old,younger than 80 years old.
  3. cT1-4a(surgically resectable tumor),N0-3,M0 at preoperative evaluation according to the American Joint Committee on Cancer(AJCC) Cancer Staging Manual Seventh Edition.
  4. No obvious surgical contraindications.
  5. American Society of Anesthesiology (ASA) score class I, II, or III.
  6. Written informed consent.
  Exclusion Criteria:
  1. Severe mental disorder.
  2. Pregnancy.
  3. History of previous gastrectomy,endoscopic mucosal resection or endoscopic submucosal dissection.
  4. History of unstable angina or myocardial infarction within past six months.
  5. History of previous neoadjuvant chemotherapy or radiotherapy.
  6. History of other malignant disease within past 5 years.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Study to Evaluate the Safety and Efficacy of Everolimus, in Subjects With PIK3CA Amplification, PTEN Loss and PIK3CA Mutation Refractory Solid Tumors

Summary: This study is a single-arm, phase II study of everolimus in patients with PTEN loss ,PIK3CA mutation and PIK3CA amplification Refractory Solid Tumors .
  Everolimus 10 mg will be administered orally qd daily.
  To investigate the efficacy and safety of everolimus in patients with PTEN loss ,PIK3CA mutantion and PIK3CA amplification Refractory Solid Tumors.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. PIK3CA amplification, PTEN loss and PIK3CA mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
  4. ECOG performance status 0-2.
  5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
  6. Adequate Organ Function Laboratory Values
  -  Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 75 x 109/L
  -  bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
  -  creatinine ≤1.5 x UNL
  7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
  8. Adequate heart function.
  Exclusion Criteria:
  1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  2. Has known active central nervous system (CNS) metastases.
  3. Has an active infection requiring systemic therapy.
  4. Pregnancy or breast feeding
  5. Patients with cardiac problem.
  6. KRAS mutation (codon 12 or 13) or BRAF mutation (V600)
  7. Any previous treatment with everolimus

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: The Pilot Study Evaluate the Safety and Efficacy of Sirolimus in Patients With PIK3CA Mutation and/or PIK3CA Amplification Refractory Solid Tumors

Summary: This study is a single-arm, phase II study of sirolimus in patient with PIK3CA mutation and PIK3CA amplication Refractory solid tumors.
  sirolimus 1mg will be administered orally qd daily.
  To investigate the efficacy of sirolimus in patients with PIK3CA mutation and PIK3CA amplication Refractory solid tumors.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. PIK3CA amplification and/or PIK3CA mutation Refractory Solid Tumors.
  4. ECOG performance status 0-2.
  5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
  6. Adequate Organ Function Laboratory Values
  -  Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L
  -  bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
  -  creatinine ≤1.5 x UNL
  7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
  8. Adequate heart function.
  Exclusion Criteria:
  1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  2. Has known active central nervous system (CNS) metastases.
  3. Has an active infection requiring systemic therapy.
  4. Pregnancy or breast feeding
  5. Patients with cardiac problem.

Relevance to patient case: possibly relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients

Summary: The aim of this study is to evaluate the efficacy of a neoadjuvant approach in patients with locally advanced gastric cancer and the identification of prognostic factors.

Detailed description: Patients with locally advanced gastric cancer (T3-4 and/or N+) are included. Initially, patients are diagnosed by computerized tomography scan and endoscopic ultrasound.
  The neoadjuvant strategy consists of 3-4 cycles of induction chemotherapy followed by concurrent chemoradiotherapy. Chemoradiotherapy comprises weekly chemotherapy concurrently with daily external beam radiotherapy up to 45 Gy). Surgery is scheduled 4 to 6 weeks after the end of CRT. Pathological response is graded according to the Becker criteria. Statistical analysis is performed IBM SPSS v20.
  Estimate whether R0 resection rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted by dynamic prognostic factors as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR)

Eligibility: Inclusion Criteria:
  -  Histologically confirmed adenocarcinoma of the stomach
  -  Age ≥18 years old
  -  Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
  -  Body mass index ≥ 18
  -  No prior chemotherapy or chemoradiotherapy
  -  TNM stage of T3-T4 and/or positive regional lymph nodes (N+) by endoscopic ultrasound or computed tomography (CT)
  -  No evidence of metastasis (M0)
  -  Adequate hematological, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL)
  Exclusion Criteria:
  -  Patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated
  -  Patients with evidence of severe or uncontrolled systemic disease
  -  Medically unfit for chemotherapy
  -  Tumors involving the esophageal junction, comprising siewert I to III

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Therapeutic Individualization for Patients With Locally Advanced Gastric and Gastroesophageal Cancer

Summary: The purpose of this study is to evaluate whether the R0 rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted in patients with locally advanced gastroesophageal junction and gastric cancer treated with a neoadjuvant approach and salvage surgery.

Detailed description: Patients with locally advanced gastroesophageal junction and gastric cancer with T3-4 and/or N+ are included. Initially, patients are diagnosed by computerized tomography scan and endoscopic ultrasound. The neoadjuvant strategy consisted of 3-4 cycles of preoperative chemotherapy (group A) or 3-4 courses of induction chemotherapy followed by concurrent chemoradiotherapy (group B). Chemoradiotherapy comprised weekly chemotherapy concurrently with daily external beam radiotherapy up to 45 Gy). Surgery is scheduled 4 to 6 weeks after the end of CRT. Pathological response is graded according to the Becker criteria. Statistical analysis is performed IBM SPSS v20. Nonlinear mixed effects (NLME) modelling is applied to evaluate the impact of dynamic changes in tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR) on the clinical outcome of these patients.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed adenocarcinoma of the stomach or gastroesophageal cancer
  -  Age ≥18 years old
  -  Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
  -  Body mass index ≥ 18
  -  No prior chemotherapy or chemoradiotherapy
  -  TNM stage of T3-T4 and/or positive regional lymph nodes (N+) by endoscopic ultrasound or computed tomography (CT)
  -  No evidence of metastasis (M0)
  -  Adequate hematological, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL)
  Exclusion Criteria:
  -  Patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated
  -  Patients with evidence of severe or uncontrolled systemic disease
  -  Medically unfit for chemotherapy

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Effect of Laparoscopy-Assisted Distal Gastrectomy for Locally Advanced Gastric Cancer

Summary: The purpose of this study is to evaluate the effect and safety of laparoscopy-assisted D2 radical surgery for distal advanced gastric cancer.

Detailed description: In both arms,subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery (4d, 4sb), hepatoduodenal ligament, superior mesenteric vein) wiil be performed basically. As a general rule, Billroth I or BillrothII methods will be used for gastric reconstruction for all cases. For anastomosis, absorbable suture is used. Anastomotic diameter is 5~6 cm length. Drainage tube is inserted through the right flank area and additional drainage tubes can be inserted as needed.

Eligibility: Inclusion Criteria:
  1. Age: older than 18 years old，including 18 years old
  2. Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma)
  3. Cancer core: located at lower part of stomach
  4. Preoperative cancer stage : cT2-4a,N0-3,M0 (according to AJCC-7th TNM staging)
  5. surgery：subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection
  6. ASA score: ≤ 3;ECOG performance status 0/1
  7. Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)
  Exclusion Criteria:
  1. Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient
  2. Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
  3. Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)
  4. Patient who was treated because of systemic inflammatory disease
  5. Pregnant patient or lactating women
  6. Patient who suffer from bleeding tendency disease, such as hemophilia or patient taking anti-coagulant medication due to deep vein thrombosis
  7. serious mental illness
  8. gastric surgery (including for gastric ESD / EMR)
  9. imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm)
  10. other malignant diseases in 5 years
  11. have unstable angina or myocardial infarction within six months
  12. have cerebral infarction or cerebral hemorrhage within 6 months
  13. sustained systemic glucocorticoid treatment history within 1 month
  14. have other diseases needed operative treatment at the same time
  15. complications (bleeding, perforation, obstruction) required emergency surgery
  16. Pulmonary function tests FEV1 <50% of predicted value.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer

Summary: This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the donafenib in advanced gastric cancer.

Detailed description: This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the tyrosine kinase inhibitor donafenib tosilate tablets (400 mg/d,200mg bid) in patients with advanced, inoperable gastric cancer progressing after chemotherapy . The primary endpoint is the safety.The secondary endpoints are tumor response and progression-free survival time.

Eligibility: Inclusion Criteria:
  -  All patients provided written, informed consent.
  -  Have histological or cytological documentation of gastric adenocarcinoma;
  -  Have received currently approved standard therapies and to have disease progression during or within 3 months after the last administration of the last standard therapy or to have stopped standard therapy because of unacceptable toxic effects.
  -  Standard therapies include as many of the following as were licensed: a fluoropyrimidine,oxaliplatin,irinotecan, paclitaxel,docetaxel;and trastuzumab for patients who had Her-2 positive tumours;
  -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  -  Life expectancy of at least 3 months;
  -  Have adequate bone-marrow, liver, and renal function at the start of the trial.
  -  Prothrombin time international normalized ratio≤1.5；
  Exclusion Criteria:
  -  Patients with brain metastases.
  -  Patients receiving cytotoxic chemotherapy, immunotherapy or hormonal therapy, radiotherapy to site of measurable or evaluable disease within the previous 4 weeks.
  -  Patients had evidence of clinically active interstitial lung disease or abnormal blood results by predefined criteria (serum bilirubin >1.5 times upper limit of reference range, aspartate or alanine aminotransferase>2.5 times the upper limit of normal if no demonstrable liver disease).

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Carvedilol as an Adjunct to Endoscopic Cyanoacrylate Injection for Secondary Prophylaxis of Gastric Variceal Bleeding

Summary: Gastric variceal obturation is the current endoscopic therapy of choice for gastric variceal bleeding but is associated with a high rebleeding rate. Carvedilol is a potent non-selective β-blocker. The role of carvedilol in the prevention of recurrent gastric variceal bleeding is not studied. This study aimed at evaluating the efficacy of carvedilol as an adjunct to gastric variceal obturation in the secondary prophylaxis of gastric variceal bleeding.

Detailed description: Gastric variceal bleeding is a lethal complication of portal hypertension. The rebleeding rate ranged between 30% to 50% in patients after initial hemostasis. Endoscopic cyanoacrylate injection is currently the choice of endoscopic therapy of acute gastric variceal bleeding and prevention of recurrent bleeding. However, the rebleeding rate is still high in the patients undergoing repeated endoscopic cyanoacrylate injection.
  Non-selective β-blockers are frequently used for the secondary prophylaxis of variceal bleeding. In the case of esophageal varices, combination of non-selective β-blockers and endoscopic therapy significantly lowers the rebleeding rate compared with endoscopic therapy alone. However, propranolol failed to decrease the rebleeding rate as an adjunct to endoscopic cyanoacrylate injection and was associated with a higher incidence of adverse effects in gastric variceal bleeding patients. A more potent non-selective β-blocker than propranolol might further decrease portal pressure and decrease the rebleeding rate.
  Carvedilol is a potent non-selective β-blocker with both beta and alpha-1 blocker effect. It significantly lowers portal pressure even in propranolol non-responders. However, it is unclear weather carvedilol will play a role in the prevention of recurrent gastric variceal bleeding. The investigators conducted a randomized controlled trial to compare the efficacy of carvedilol combined with endoscopic cyanoacrylate injection with endoscopic cyanoacrylate injection alone in secondary prophylaxis of gastric variceal bleeding.

Eligibility: Inclusion Criteria:
  -  Age of 20 to 80 years
  -  Cirrhotic patients with acute gastric variceal bleeding proven by an endoscopy within 24 h of bleeding
  -  Stable hemodynamic condition for at least 3 days after cyanoacrylate injection
  Exclusion Criteria:
  -  Previous treatment of gastric varices, including endoscopic therapy, transjugular intrahepatic porto-systemic shunt, or surgery
  -  Contraindications to non-selective beta-blockers or cyanoacrylate injection
  -  Serum total bilirubin >10 mg/dL
  -  Grade III/IV hepatic encephalopathy
  -  Hepato-renal syndrome
  -  Severe heart failure (NYHA Fc III/IV)
  -  Chronic kidney disease under renal replacement therapy
  -  Refractory ascites
  -  Malignancy other than hepatocellular carcinoma
  -  Pregnancy
  -  Pacemaker use
  -  Refusal to participate

Relevance to patient case: not relevant