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

NCT ID: NCT05023109

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2024-12-01

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.

Conditions

Biliary Tract Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GP+PD-1+Tight

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.

Group Type: EXPERIMENTAL

GP+PD-1+Tight

Intervention Type: DRUG

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

Interventions

GP+PD-1+Tight

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jining Medical University

OTHER

Sponsor Role: collaborator

Cancer Hospital of Guangxi Medical University

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia Fan

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

Zhongshan hospital

Shanghai, , China

Countries

China

Other Identifiers

ZSAB-TOP

Identifier Type: -

Identifier Source: org_study_id