Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Hepatocellular

Biliary Tract Neoplasms

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Biliary Tract Diseases

Biliary Tract Cancer

Hematinics

All Drugs and Chemicals

Liver Extracts

All patients should accept next-generation sequencing (NGS) test before treatment.

During screening stage, all patients should accept next-generation sequencing (NGS) test.

precise medicine

Bixiang Zhang, PhD

Ze-yang Ding, M.D.

Wanguang Zhang

Zeyang Ding

Exploring the precise medicine of patients with primary hepatobiliary cancer. And evaluate the efficacy and safety of individualized treatment regimens for primary hepatobiliary cancer based on next-generation sequencing.

The purpose of this study is to explore the precise treatment in hepatobiliary cancer patients and evaluate drug efficacy, progression free and overall survival. This trial study is based on genetic tests, then therapeutic target drugs are administered according to the genetic test reports. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit from precise treatment which targets particular genetic abnormality. The identifications of these genetic abnormalities may help treat hepatobiliary cancer patients.

The genetic tests are performed for the eligible subjects in this study, then therapeutic target drugs are administered according to the genetic test reports. While the precise treatments, follow-ups are conducted to evaluate the efficacy and safety of the target drugs for the subjects, until the overall survival.

The samples, both tissue(s) and blood of patients should be provided for the High-Throughput Sequencing test before screening.

Ambispective Cohort Study of Precision Medicine for Primary Hepatobiliary Cancer Based on Next-generation Sequencing

The data have the gene mutations information of patients.

Time of progression will be obtained by telephone interview or medical treatment records.

Include all-cause death of patients in this study.

Percentage of patients whose tumors have a complete or partial response to treatment.

The proportion of patients who had either stable disease (SD) for ≥ 6 months, a CR or PR after initiation of treatment for HCC

duration from the first assessment of the tumor was CR or PR to the time that the first assessment for PD or date of death from any cause

Patients with treatment-related adverse events as assessed by CTCAE v4.0.

The life quality of every subject will be assessed every 3 months according to the FACT-Hep questionnaire, which assesses generic HRQL concerns and disease-specific issues.

Tongji Hospital

Chairman of Department of General Surgery

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

CTX-benefit group: based on the result of nProfiler Stomach cancer assay kit which was decided by expression level of mRNA, this group will be beneficial from adjuvant chemotherapy

no-benefit group: based on the result of nProfiler Stomach cancer assay kit which was decided by expression level of mRNA, this group will not be beneficial from adjuvant chemotherapy

high-risk group: based on the result of nProfiler Stomach cancer assay kit which was decided by expression level of mRNA, the prognosis of this group will be worse compared to others regardless of the response to adjuvant chemotherapy

To conduct a retrospective study to prove a hypothesis of "adjuvant chemotherapy provides survival benefit for patients of CTX-benefit group in gastric cancer of pT1N1, especially in high-risk group". This study is a pilot study and the result will be used as a reference for the upcoming prospective randomized controlled trial for same issue including estimating sample size. Two high-volume hospitals (Yonsei University Severance Hospital and Samsung Hospital) will participant this pilot study.

FFPE sample blocks and clinical information pertaining to the patients who satisfied with selection criteria will be collected from two institutions. The primary end point of this study is disease-free survival (DFS) that is defined as the time from surgery to death or gastric cancer recurrence whichever occurred first; and overall survival (OS) that is defined as time from surgery to death by any causes. Clinical information such as age, sex, histology, Lauren classification, depth of invasion, number of retrieved and metastatic lymph nodes, sizes of tumor, location of tumor, gross type, lympho-vascular invasion, received chemotherapy or not will be centralized.

One or 2 of 3mm core of tumor will be punched from FFPE and it will be delivered through Eppendorf tube to laboratory (Novomics Co. Ltd., Seoul, Korea). RNA will be extracted from the tissue and the pattern of RNA expression will be evaluated and each sample will be categorized into three risk group (high, intermediate, low risk group) and two predictive group (CTX-benefit and no-benefit group) by GMP-grade nProfiler 1TM Stomach Cancer Assay Kit (Novomics Co. Ltd., Seoul, Korea). Both clinical information and classification will be delivered to independent statisticians who are responsible to conduct statistical analyses.

specimen including mRNA from formalin fixed paraffin embeded tissue

Prediction of Benefit From Adjuvant Chemotherapy for pT1N1 Gastric Cancer

Prediction of Benefit From Adjuvant Chemotherapy for pT1N1 Gastric Cancer: A Pilot Retrospective Multicenter Cohort Study

Disease free survival which is defined as the time from surgery to death or gastric cancer recurrence whichever occurred first, and overall survival that is defined as time from surgery to death by any causes

overall survival that is defined as time from surgery to death by any causes. Survival difference between surgery only vs. surgery plus adjuvant treatment (chemotherapy or chemo-radiotherapy) will be analyzed according to subgroup (CTX-benefit and no-benefit group in overall and high-risk group)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ambispective Cohort Study of Precision Medicine for Primary Hepatobiliary Cancer Based on Next-generation Sequencing	NCT05520788	Hepatocellular ... Biliary Tract C...	precise medicin...	18 Years -	Tongji Hospital
Prediction of Benefit From Adjuvant Chemotherapy for pT1N1 Gastric Cancer	NCT03485105	Gastric Cancer		20 Years - 85 Years	Yonsei University

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