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

Clinical trial: Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer

Summary: -  To date, Roux-en-Y esophagojejunostomy transabdominal extracorporeally by circular stapler was the most common used method during laparoscopy-assisted total gastrectomy for gastric cancer, even though it was not totally laparoscopic surgery in which intracorporeal anastomosis should be performed.
  -  To gain potential clinical benefits from a smaller length of minilaparotomy and an easier anastomosis technique than extracorporeal anastomosis, intracorporeal Roux-en-Y anastomosis using a transorally inserted anvil (OrVil™) during totally laparoscopic total gastrectomy was adopted by experienced surgeons recently.
  -  However, the safety of intracorporeal Roux-en-Y esophagojejunostomy using a transorally inserted anvil (OrVil™) has not yet been evaluated. Thus, the study comparing the safety of intracorporeal versus extracorporeal Roux-en-Y esophagojejunostomy by circular stapler based on a well designed randomized controlled trial is needed.


Eligibility: Inclusion Criteria:
  -  Age from over 18 to under 75 years
  -  Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy
  -  Tumor located at middle or upper third of stomach while laparoscopic total gastrectomy is the planning surgery
  -  Tumor invasion is less than 3cm above the esophagogastric junction
  -  Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
  -  ASA (American Society of Anesthesiology) score class I, II, or III
  -  Written informed consent
  Exclusion Criteria:
  -  Women during pregnancy or breast-feeding
  -  Severe mental disorder
  -  History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  -  Conversion to open surgery before reconstruction

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

Clinical trial: Validation of MMS Test for Cancer Monitoring

Summary: The purpose of this study is the validation of MMS test to detect active tumor growth in different cancer types before and after therapy, as well as in the course of therapy and for subsequent relapse control compared to standard methods (clinical examination, imaging, tumor markers). It should be consider whether the MMS test has comparable diagnostic accuracy, and thus can replace more expensive or invasive procedures in future.


Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of colo-rectal cancer
  -  Clinical diagnosis of stomach cancer
  -  Suspected diagnosis of melanoma
  Exclusion Criteria:
  -  Colitis ulcerosa
  -  Morbus Crohn
  -  Cancer in time period two years before
  -  Cancer therapy in time period two years before

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

Clinical trial: Investigation of the Proportion of Human Epidermal Growth Factor Receptor 2 Protein Overexpression of Gastric Adenocarcinoma and Prognostic Effect of HER2, and Analysis of Practice Pattern of Herceptin Use in Stage IV Gastric Cancer

Summary: The objective of this study is to investigate the proportion of HER2 overexpression in gastric cancer patients group, to evaluate the relation of HER2 overexpression with prognosis, and to analyze the proportion of herceptin applied to patients in clinical field. Furthermore, the investigators are going to reevaluate the clinical benefit of Herceptin for survival prolongation compared to chemotherapy only.


Eligibility: Inclusion Criteria:
  1. Histologically confirmed gastric adenocarcinoma
  2. Patients were diagnosed during 2006-2013
  3. HER2 expression status was evaluated in primary gastric cancer or metastatic lesion.
  Exclusion Criteria:
  -  Patients with second primary cancer within 5 years

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

Clinical trial: Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer

Summary: This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in non-small cell lung cancer

Detailed description: This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus etoposide/cisplatin with concurrent radiotherapy in stage III non-small cell lung cancer with EGFR 19/21 Mutation, the primary endpoint is progression-free survival

Eligibility: Inclusion Criteria:
  -  Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation
  -  No previous systemic anticancer therapy
  -  Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
  -  ECOG Performance Status of 0 to 1
  Exclusion Criteria:
  -  Prior treatment with anti-EGFR (the epidermal growth factor receptor) monoclonal antibody or small molecular compounds therapy such as gefitinib, erlotinib or cetuximab
  -  Evidence of clinically active Interstitial Lung Diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
  -  Known severe hypersensitivity to icotinib or any of the excipients of this product

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

Clinical trial: Study of EGFR-TKI to Asymptomatic Brain Metastases of NSCLC

Summary: The purpose of this study is to determine whether EGFR-TKI can control the development of intracranial lesions in Non Small Cell Lung Cancer patients with asymptomatic brain metastases, and the difference in progression free survival between exon 19 and exon 21 mutations.

Detailed description: A open, positive control of phase II clinical trials, divided into selection period, treatment period and follow-up period , comply with the standard set of participants signed a written informed consent, according to different divided into 19 patients with EGFR mutations outside show son mutation group) and 21 extra show mutations, and according to the ECOG physical status, age, previous systemic treatments such as hierarchical analysis, regular follow-up and to assess efficacy, life care and safety.

Eligibility: Inclusion Criteria:
  1. at the age of 18 -70 years old, male or female
  2. the non-small cell lung cancer diagnosed by histopathology
  3. detected by ARMS to confirm that the EGFR sensitive mutant patients
  4. the existence of MRI diagnosis of intracranial metastatic head enhancement, and the presence of imaging evaluating lesions (according to RECIST1.1)
  5. have not received prior treatment of intracranial metastases, including radiotherapy, gamma knife, chemotherapy drugs
  6. no brain metastasis symptoms, including, increased intracranial pressure, no vomiting, ignoring the papillary edema, no headache, without hemiplegia, ignore things not clear, without epilepsy
  7. PS:0 or 1
  8. the expected survival time 3 months &gt;
  9. patients signed informed consent voluntarily
  Exclusion Criteria:
  1. 4 weeks before entering the group received operation or operation, the wound has not healed completely
  2. into group 2 weeks before receiving immune therapy or treatment of traditional Chinese Medicine
  3. serious cardiovascular diseases, including Department of internal medicine, uncontrolled hypertension, unstable angina, myocardial infarction history exists within the past June, severe arrhythmia or pericardial effusion
  4. serious infection, need intravenous antibiotic, antifungal or antiviral treatment
  5. before entering the group 4 weeks participated in any study drug clinical trial
  6. there are serious tumor invasion, oppression by the main bronchus or bronchial stenosis or obstruction, superior vena cava syndrome
  7. the existence of herniation of brain tumor apoplexy, epilepsy, and frequent
  8. suffering from a mental illness, poor compliance
  9. the researchers think that do not fit into the group of cases

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

Clinical trial: Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer

Summary: The purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic spleen-preserving No. 10 lymph node dissection in a left-sided approach for advanced middle or upper third gastric cancer.

Detailed description: A prospective randomized comparison of laparoscopic spleen-preserving No. 10 lymph node dissection for gastric cancer will be performed, to evaluate the short-term, long-term and oncological outcomes. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Eligibility: Inclusion Criteria:
  -  Age from 18 to 75 years
  -  Primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  -  cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  -  No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
  -  Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
  -  American Society of Anesthesiology score (ASA) class I, II, or III
  -  Written informed consent
  Exclusion Criteria:
  -  Women during pregnancy or breast-feeding
  -  Severe mental disorder
  -  History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  -  History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
  -  Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
  -  History of other malignant disease within past five years
  -  History of previous neoadjuvant chemotherapy or radiotherapy
  -  History of unstable angina or myocardial infarction within past six months
  -  History of cerebrovascular accident within past six months
  -  History of continuous systematic administration of corticosteroids within one month
  -  Requirement of simultaneous surgery for other disease
  -  Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  -  FEV1＜50% of predicted values

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

Clinical trial: A Study Evaluating Safety and Pharmacokinetics of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor

Summary: This is an open-label, Phase I, dose escalation study to determine the recommended Phase 2 dose, maximum tolerated dose, and evaluate the safety and pharmacokinetic profile of ABBV-221 in participants with advanced solid tumors likely to exhibit elevated levels of Epidermal Growth Factor Receptor (EGFR).


Eligibility: Inclusion Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2.
  -  Has a solid tumor likely to exhibit elevated levels of EGFR (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer ,colorectal carcinoma and glioblastoma multiforme).
  -  Has an archived, diagnostic tumor tissue available for analysis.
  -  Has adequate hematologic, renal, cardiac and hepatic function.
  -  Expanded Safety Cohort participants must have confirmed metastatic lung cancer and progressed after receiving prior platinum-containing chemotherapy.
  Exclusion Criteria:
  -  Previously received an EGFR-directed monoclonal antibody within the past 4 weeks.
  -  Has unresolved, clinically significant toxicities from prior anti-cancer therapy defined as > Grade 1 on Common Terminology Criteria for Adverse Events.
  -  History of major immunologic reaction to any IgG containing agent.
  -  Any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.

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

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

Clinical trial: A Phase 1 Study of KBP-5209 in Patients With Advanced Solid Tumors

Summary: The purpose of this study is to determine the maximum tolerated dose of KBP-5209 as a single agent when given orally to adult patients with advanced solid tumors that have progressed despite standard therapy, or where there is no standard therapy.

Detailed description: This is a Phase 1, open-label, multicenter study of KBP-5209 administered orally once daily (QD) in 28-day treatment cycles to adult patients with advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists. This study is designed to determine the MTD or RP2D and to characterize the safety, tolerability, and PK profile of KBP-5209.

Eligibility: Inclusion Criteria:
  -  Age 18 years or older;
  -  Patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists.
  -  Patients must have at least one measurable or non-measurable lesion (dose escalation only) as defined by RECIST v1.1
  -  Eastern Cooperative Oncology Group performance score 0 to 2;
  Exclusion Criteria:
  -  Patients with symptomatic CNS metastases;
  -  Patients who have a known history of hepatitis C or chronic active hepatitis B or a known diagnosis of HIV
  -  Any significant ophthalmologic abnormality
  -  Patients who have any severe and/or uncontrolled medical conditions
  -  Significant gastrointestinal abnormalities,
  -  Patients who have impaired cardiac function or clinically significant cardiac diseases,
  -  Chemotherapy, biologic therapy, immunotherapy, radiotherapy or investigational agents within 5 half-lives or within 4 weeks (whichever is longer) prior to administration of the first dose of study drug on Day 1 or have not recovered from the side effects of such therapy;
  -  Treatment with third generation EGFR inhibitors
  -  Major surgery/surgical therapy for any cause within 4 weeks of Screening;

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

Clinical trial: A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer

Summary: The main purpose of this study is to evaluate the safety and preliminary efficacy of the combination of the study drug known as ramucirumab plus pembrolizumab in participants with locally advanced and unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), transitional cell carcinoma of the urothelium, or biliary tract cancer (BTC).


Eligibility: Inclusion Criteria:
  -  Metastatic disease or locally advanced, unresectable disease.
  -  Has histopathologically confirmed gastric or GEJ adenocarcinoma with documented disease progression after 0-2 prior lines of systemic therapy
  -  Has histopathologically confirmed nonsquamous or squamous NSCLC with documented disease progression after 0-3 prior lines of systemic therapy
  -  Has histopathologically confirmed transitional cell carcinoma of the urothelium (bladder, urethra, or renal pelvis) with documented disease progression after 1-3 prior lines of systemic therapy
  -  Has histologically confirmed biliary tract adenocarcinoma with documented progression after 1-2 prior lines of systemic therapy
  -  Availability of tumor tissue for biomarker analysis from a newly obtained core or excisional biopsy or willing to undergo a tumor biopsy. For first line NSCLC participants only, PD-L1 expression should be 1% or higher.
  -  Have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  -  Has adequate organ function.
  -  Have an anticipated life expectancy of ≥3 months.
  Exclusion Criteria:
  -  Have known brain metastases.
  -  Has received ≥3 lines of prior systemic therapy for gastric or GEJ adenocarcinoma and BTC or ≥4 lines for NSCLC or urothelial cancer.
  -  Has active autoimmune disease.
  -  Known human immunodeficiency virus (HIV) infection.
  -  Known active hepatitis B or hepatitis C infection.
  -  Has received any previous systemic therapy targeting vascular endothelial growth factor (VEGF) or VEGF receptor, or programmed death (PD) 1 or PD-ligand 1/2 signaling pathways.
  -  Have received a live vaccine within 30 days prior to enrollment. Seasonal flu vaccines that do not contain live virus are permitted.
  -  Have had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment.
  -  Have an elective or a planned major surgery during the course of the trial or has undergone major surgery within 28 days prior to enrollment.

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

Clinical trial: Study for Treatment of Patients With EGFR Mutant, T790M-negative NSCLC

Summary: This phase 2 study is designed to evaluate the safety and activity of TH-4000 (Tarloxotinib), a hypoxia-activated prodrug, in patients with EGFR-Mutant, T790M-Negative, Advanced non-small cell lung cancer (NSCLC).

Detailed description: A single arm open label multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 (Tarloxotinib) will be assessed in patients with EGFR mutant, T790M negative advanced NSCLC. Patients must have demonstrated progression during EGFR TKI therapy.
  Hypoxia PET scans will be obtained in select centers to analyze potential predictors of tumor response.

Eligibility: Key Eligibility Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  -  Confirmed recurrent Stage IV NSCLC which progressed while on treatment with EGFR TKI
  -  Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
  -  Documented evidence of an EGFR mutation known to be associated with an EGFR TKI sensitivity
  -  No T790M mutation or small cell transformation including an assessment from tumor biopsy obtained while on or subsequent to the most recent EGFR TKI therapy
  -  Acceptable laboratory results as indicated by protocol
  -  Acceptable cardiac function as indicated by protocol
  Key Exclusion Criteria:
  -  Receiving medication that prolongs QT interval, with a risk of causing Torsades de Pointes (TdP) unless ECG meets inclusion criteria while on a stable dose of the medication
  -  Family history of long QTc syndrome
  -  Symptomatic central nervous system (CNS) lesions
  -  Radiation therapy within 2 weeks prior to the first dose of study medication
  -  Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
  -  Concurrent active malignancy requiring systemic treatment
  -  Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus [HIV]), recent (within 6 months) myocardial infarction or unstable angina, congestive heart failure, poorly-controlled hypertension or diabetes, concurrent active malignancy, or psychiatric condition that may interfere with the patient's ability to follow study procedures
  -  Pregnant or breast-feeding

Relevance to patient case: not relevant