Clinical trial · Interventional
GP Chemotherapy in Combination With Anti-PD-1 and Anti-TIGIT in Unresectable Advanced BTC
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)
NCT05023109CI-TRIAL-00068811unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Carcinoma | Biliary Tract Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GP+PD-1+Tight | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GP+PD-1+Tight
- 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.
- interventionNames
- Drug: GP+PD-1+Tight
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 24 months
- description
- ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs
Secondary outcomes (7)
- measure
- Disease control rate (DCR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDShi G, Huang X, Ma L, Li H, Zhong J, Wang J, Gao Q, Guo X, Qiu S, Sun H, Shi Y, Huang X, Wang X, Yi Y, Zhu X, Huang C, Ding Z, Chen Y, He Y, Shen Y, Sun Q, Zhou J, Fan J. First-line tislelizumab and ociperlimab combined with gemcitabine and cisplatin in advanced biliary tract cancer (ZSAB-TOP): a multicenter, single-arm, phase 2 study. Signal Transduct Target Ther. 2025 Aug 21;10(1):260. doi: 10.1038/s41392-025-02356-y. PMID 40835595