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GP Chemotherapy in Combination With Anti-PD-1 and Anti-TIGIT in Unresectable Advanced BTC

Primary Purpose

Biliary Tract Carcinoma

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
GP+PD-1+Tight
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Subjects with a histopathological or cytologically diagnosis of BTC

    • The participants must be required to sign an informed consent
    • At least one measurable lesion (RECIST 1.1)
    • No previous systematic treatment for BTC
    • Child-Pugh Score, Class A
    • ECOG performance status 0 or 1
    • Adequate organ function
    • Life expectancy of at least 3 months

Exclusion Criteria:

  • • Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma

    • Known history of a serious allergy to any monoclonal antibody
    • Known central nervous system metastases and/or leptomeningeal disease prior to treatment
    • Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment
    • Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
    • Any active malignancy prior to the start of treatment
    • Active or history of autoimmune disease
    • Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
    • Pregnant or lactating women

Sites / Locations

  • Zhongshan hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GP+PD-1+Tight

Arm Description

Tislelizumab 200mg IV Q3W + Ociperlimab 900mg IV Q3W + GP (gemcitabine 1000mg/m2 + cisplatin 25mg/m2 Q3W) Gemcitabine/Cisplatin will be administered on D1/D8 in every three weeks cycle and up to 8 cycles. Tislelizumab and Ociperlimab will be administered on D1 in every three weeks cycle, until the disease progression, intolerable toxicity, death, withdrawal of consent.

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs

Secondary Outcome Measures

Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR or PR or SD to study drugs
Duration of response (DoR)
DoR is defined as the time interval from first meeting response criteria (CR or PR) to confirmed progressive disease (PD) or death, whichever occurs first.
Progression-free survival (PFS)
PFS is defined as the time from the date of treatment to the first documented disease progression or death due to any cause, whichever occurs first.
6-months/12-months PFS rate
6-months/12-months PFS rate is defined as the proportion of patients alive and free of disease progression at 6 months/12 months.
Overall Survival (OS）
OS is defined as the time from the treatment until death due to any cause.
6-months/12-months OS rate
OS rate is defined as the proportion of patients who have not experienced death from any cause at 6 months/12 months.
Adverse Events (AEs)
The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0

Full Information

First Posted
August 20, 2021
Last Updated
August 12, 2023
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Jining Medical University, Cancer Hospital of Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05023109
Brief Title
GP Chemotherapy in Combination With Anti-PD-1 and Anti-TIGIT in Unresectable Advanced BTC
Official Title
A Study to Evaluate GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Participants With Unresectable Advanced Biliary Tract Carcinoma (BTC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
January 18, 2023 (Actual)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Jining Medical University, Cancer Hospital of Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of GP (Gemcitabine/Cisplatin) in combination with Tislelizumab and Ociperlimab as first-line treatment in participants with unresectable advanced Biliary Tract Carcinoma (BTC).
Detailed Description
Biliary Tract Carcinoma (BTC) has an insidious onset, invasiveness, high malignancy, and no specific symptoms in the early stage, and most of them are in the middle and advanced stages at the time of diagnosis and have lost the chance of surgery. For patients with advanced BTC, systemic therapy is currently the main choice, and gemcitabine/cisplatin (GP) is currently the "gold standard" for first-line treatment of advanced BTC, but the efficacy is still unsatisfactory, and more and more clinical practice has found that GP-based combination therapy may have better efficacy. Previous studies have shown that chemotherapy can improve the immunotherapy microenvironment and may have a synergistic anti-tumor effect in combination with immunotherapy. This study is to explore the efficacy and safety of GP in combination with anti-PD1 antibody (Tislelizumab) and anti-TIGIT antibody (Ociperlimab) as first-line treatment in participants with unresectable advanced BTC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GP+PD-1+Tight
Arm Type
Experimental
Arm Description
Tislelizumab 200mg IV Q3W + Ociperlimab 900mg IV Q3W + GP (gemcitabine 1000mg/m2 + cisplatin 25mg/m2 Q3W) Gemcitabine/Cisplatin will be administered on D1/D8 in every three weeks cycle and up to 8 cycles. Tislelizumab and Ociperlimab will be administered on D1 in every three weeks cycle, until the disease progression, intolerable toxicity, death, withdrawal of consent.
Intervention Type
Drug
Intervention Name(s)
GP+PD-1+Tight
Intervention Description
Drug: Tislelizumab Tislelizumab 200mg IV Q3W Other Name: BGB-A317 Anti-PD-1 therapy Drug: Ociperlimab Ociperlimab 900mg IV Q3W Other Name: BGB-A1217 Anti-TIGIT therapy Drug: GP chemotherapy gemcitabine 1000mg/m2 + cisplatin 25mg/m2 Q3W
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Disease control rate (DCR)
Description
DCR is defined as the proportion of subjects with CR or PR or SD to study drugs
Time Frame
24 months
Title
Duration of response (DoR)
Description
DoR is defined as the time interval from first meeting response criteria (CR or PR) to confirmed progressive disease (PD) or death, whichever occurs first.
Time Frame
24 months
Title
Progression-free survival (PFS)
Description
PFS is defined as the time from the date of treatment to the first documented disease progression or death due to any cause, whichever occurs first.
Time Frame
24 months
Title
6-months/12-months PFS rate
Description
6-months/12-months PFS rate is defined as the proportion of patients alive and free of disease progression at 6 months/12 months.
Time Frame
6 months/12 months
Title
Overall Survival (OS）
Description
OS is defined as the time from the treatment until death due to any cause.
Time Frame
24 months
Title
6-months/12-months OS rate
Description
OS rate is defined as the proportion of patients who have not experienced death from any cause at 6 months/12 months.
Time Frame
6 months/12 months
Title
Adverse Events (AEs)
Description
The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Subjects with a histopathological or cytologically diagnosis of BTC The participants must be required to sign an informed consent At least one measurable lesion (RECIST 1.1) No previous systematic treatment for BTC Child-Pugh Score, Class A ECOG performance status 0 or 1 Adequate organ function Life expectancy of at least 3 months Exclusion Criteria: • Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma Known history of a serious allergy to any monoclonal antibody Known central nervous system metastases and/or leptomeningeal disease prior to treatment Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment Any active malignancy prior to the start of treatment Active or history of autoimmune disease Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Fan
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

GP Chemotherapy in Combination With Anti-PD-1 and Anti-TIGIT in Unresectable Advanced BTC

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