Clinical trial · Interventional
GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Advanced BTC
A Study to Evaluate GP Chemotherapy in Combination With Tislelizumab(Anti-PD-1) and Ociperlimab(Anti-TIGIT) as First-line Treatment in Participants With Unresectable Advanced BTC
NCT05019677CI-TRIAL-00057542withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Repeat registration
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 |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | 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
- Experimental: 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 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 (0)
Data not yet available
No reference posted for this study.