Neoplasms

All Conditions

Rare Diseases

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

All Drugs and Chemicals

Immunomodulating Agents

Blood samples, tumor biopsy specimens at baseline will be collected

Blood samples, tumor biopsy specimens will be collected

Jieer Ying, Dr

Jieer Ying, Doctor

Biospecimen Retention Ying, Dr

A prospective, observational study to explore multidimensional biomarkers for predicting the efficacy of immunotherapy In biliary tract tumors

Patient with unresectable advanced or metastatic biliary tract tumors will be enrolled and plan to receive PD-1/PD-L1 inhibitors combined with chemotherapy as first-line treatment. To explore the biomarkers, tumor tissues, acquired from puncture biopsies at baseline, will be collected and investigated by genomic panel sequencing , transcriptome sequencing, and mIHC. Meanwhile, baseline peripheral blood and feces were also collected for detection of plasma proteins, genomes, and metagenomes. Finally, the investigators will analysis and explore predictive biomarkers of immunotherapy in biliary tract tumors.

Prospective Observational Study to Predict the Response of Biliary Tract Tumors to Immunotherapy

Prospective Observational Study on Prediction of Response to First-line Immunotherapy in Patients With Biliary Tract Tumors

ldentifying predictive biomarkers of immunotherapy response by detecting differences in genome and transcriptome sequencing between responder and non-responder patients

Zhejiang Cancer Hospital

Principal Investigator

Antineoplastic Agents

Oxaliplatin

Capecitabine

Lenvatinib

Tislelizumab

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

All patients will be treated with the combination of tisleizumab , lenvatinib and XELOX regimen (oxaliplatin combined with capecitabine) until disease progression , unacceptable toxicity, death or the patient meets any other discontinuation criteria described in the protocol, whichever occurs first. Subjects can receive up to 8 cycles of the XELOX regimen. For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen, treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years.

Tisleizumab 200 mg intravenously (IV) every 3 weeks (Q3W) ,D1

Lenvatinib 8 mg (for patient weight \< 60 kg) or 12 mg (for patient weight ≥ 60 kg), orally, QD, D1-21, Q3W

Oxaliplatin 130 mg/m2, IV， D1，Q3W

Subjects can receive up to 8 cycles of the XELOX regimen (Oxaliplatin and Capecitabine). For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen, treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years.

Capecitabine 1000 mg/m2, orally, BID, D1-14, Q3W

Subjects can receive up to 8 cycles of the XELOX regimen (Oxaliplatin and Capecitabine). For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen, treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years.

Yongxiang Xia, Doctor

Jie Zhao, Doctor

Yongxiang Xia

jie Zhao

This study is a single-center, single-arm, open-label clinical study. All patients with advanced and unresectable biliary tract tumors will be treated with the combination of tisleizumab, lenvatinib and XELOX regimen (oxaliplatin plus capecitabine) until disease progression , unacceptable toxicity, death or the patient meets any other discontinuation criteria described in the protocol, whichever occurs first. Subjects can receive up to 8 cycles of the XELOX regimen. For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen, treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years. Patients will be closely monitored for safety and tolerability throughout the study.

Tisleizumab Combined With Lenvatinib and XELOX Regimen (Oxaliplatin Combined With Capecitabine) in the First-line Treatment of Advanced and Unresectable Biliary Tract Tumors

A Single-arm, Open-label Clinical Study of Combined Therapy of Tisleizumab , Lenvatinib and XELOX Regimen (Oxaliplatin Combined With Capecitabine) in the First-line Treatment of Advanced and Unresectable Biliary Tract Tumors

It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR.

Safety will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0

ORR assessed by the investigator according to iRECIST

Disease control rate (DCR) assessed by the investigator according to RECIST v1.1 and iRECIST

DOR assessed by the investigator according to RECIST v1.1 and iRECIST

progression-free survival (PFS) assessed by the investigator according to RECIST v1.1 and iRECIST

The First Affiliated Hospital with Nanjing Medical University

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Hematinics

Liver Extracts

for each patient: liver sampling, blood samples ( serum, plasma, PBMC, whole blood), per-endoscopic bile sampling, stool samples, and materials derived from fresh tumors

Tumor samples

Christophe Tournigand, MD-PHD

Ilaria Cascone, PHD

Pr Tournigand

Colorectal and pancreatobiliary cancers are the most common digestive cancers. Their incidence has particularly increased over the last few decades, leading to suspicion that environmental factors are involved. In addition, strategies for the therapeutic management of these cancers are evolving in the context of the development of immunotherapies.

Tumor microenvironment is a potential source of new diagnostic, prognostic and predictive markers and new therapeutic targets. The links between tumor microenvironment and modulation of the immune system in colorectal and pancreatobiliary cancers are poorly understood. Molecular classifications have been proposed for these cancers, but their link with immunity and response to treatment remains to be explored.

Objective : explore links between molecular subtypes, tumor microenvironment, host (immune system, pre-metastatic niche, intestinal microbiota, metabolism), and survival (prognostic value), response (predictive value) and tolerance (toxicities) to treatments in digestive cancers, in particular colorectal and pancreatobiliary cancers.

Method: Retrospective and prospective monocentric cohort study

Retrospective and prospective monocentric cohort study

Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort

Interactions Between Tumor, Tumor Microenvironment and Immune System in Digestive Cancers : Impact on Survival and Response to Treatment

AP-HP is the owner of the data and no use or transmission to a third party may be made without its prior consent.

Overall survival (OS): vital status (alive/deceased)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Observational Study to Predict the Response of Biliary Tract Tumors to Immunotherapy	NCT06048289	Biliary Tract T... Cholangiocarcin...	Blood samples, ...	18 Years -	Zhejiang Cancer Hospital
Tisleizumab Combined With Lenvatinib and XELOX Regimen (Oxaliplatin Combined With Capecitabine) in the First-line Treatment of Advanced and Unresectable Biliary Tract Tumors	NCT05291052	Biliary Tract T...	Tislelizumab Lenvatinib Oxaliplatin Capecitabine	18 Years - 75 Years	The First Affiliated Hospital with Nanjing Medical University
Prospective Observational Study to Predict the Response of Biliary Tract Tumors to Immunotherapy	NCT06048289	Biliary Tract T... Cholangiocarcin...	Blood samples, ...	18 Years -	Zhejiang Cancer Hospital
Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort	NCT04707365	Colorectal Canc... Pancreas Tumor Biliary Tract T... Immune System a...	Tumor samples	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for biliary tract tumor