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A Study of the Efficacy and Safety of Chemotherapy Combined With Toripalimab in Advanced Biliary Tract Cancer

NCT03796429 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-11-29

No results posted yet for this study

Summary

1. Target population: patients with advanced biliary tract cancer (including gallbladder carcinoma, intrahepatic and extrahepatic cholangiocarcinoma) .
2. Primary objective: progression free survival (PFS)/ overall survival (OS) of first-line chemotherapy plus PD-1 antibody (Toripalimab) in patients with advanced biliary tract cancer.

Secondary objectives:

1. objective response rate (ORR) of first-line chemotherapy plus PD-1 antibody (Toripalimab)
2. safety of first-line chemotherapy plus PD-1 antibody (Toripalimab)

3.Trial design: This is a monocenter, single arm, phase II study to evaluate the efficacy and safety of first-line chemotherapy plus PD-1 antibody (Toripalimab) in patients with advanced advanced biliary tract cancer.

4.Treatment plan: Patients will be given treatment as below once recruited: PD-1 antibody Toripalimab（240mg, iv, q3w），combined with GS regimen(gemcitabine 1000mg／m2 ，d1,d8 + S1 40-60mg bid\*14d，Q21d).

The treatment will be continued until emerging of disease progression or intolerable adverse effects (The upper time limit for treatment is 2 years).

5.Number of subjects: 40 patients. Number of centers: 1 sites ( Fudan University Affiliated Zhongshan Hospital).

Conditions

  • Biliary Tract Cancer

Interventions

DRUG

GS+Toripalimab

Patients will be given treatment as below once recruited: PD-1 antibody Toripalimab（240mg, iv, q3w），combined with GS regimen(gemcitabine 1000mg／m2 ，d1,d8 + S1 40-60mg bid\*14d，Q21d). The treatment will be continued until emerging of disease progression or intolerable adverse effects (The upper time limit for treatment is 2 years).

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    collaborator OTHER

  • OrigiMed

    collaborator INDUSTRY

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Tianshu Liu, Doctor · Shanghai Zhongshan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-17
Primary Completion
2021-12-01
Completion
2022-03-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03796429 on ClinicalTrials.gov