Clinical trial · Interventional
Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC
Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer: a Randomised, Open-label, Parallel-group, Multicenter Phase III Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in the treatment of participants with previously untreated locally advanced or metastatic biliary tract cancer. The primary hypothesis of this study is that participants will have a longer overall Survival (OS) when treated with combined therapy than SOC.
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 Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine & oxaliplatin | Drug | — | UNRESOLVED |
| KN035 plus Gemcitabine & oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- KN035
- description
- KN035 plus Gemcitabine \& oxaliplatin KN035 2.5 mg/Kg, administered as subcutaneous injection, weekly of each 21-day cycle. Gemcitabine 1000 mg/m\^2, IV infusion on Day 1 and Day 8, and oxaliplatin 85 mg/m\^2, IV infusion on Day 1 of each 21-day cycle for no more than 6 cycles.
- interventionNames
- Drug: KN035 plus Gemcitabine & oxaliplatin
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine & oxaliplatin
- description
- Gemcitabine 1000 mg/m\^2, IV infusion on Day 1 and Day 8, and oxaliplatin 85 mg/m\^2, IV infusion on Day 1 of each 21-day cycle for no more than 6 cycles.
- interventionNames
- Drug: Gemcitabine & oxaliplatin
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eighteen years and older; * Histological or cytological diagnosis of unresectable or metastatic gallbladder cancer or cholangiocarcinoma; * Previously untreated with systemic therapy; Subjects who developed recurrent disease \>6 months after a sort of adjuvant, neoadjuvant chemotherapy could also be eligible. * Liver function Child-Pugh A or B; * Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status; * Life expectancy of at least 12 weeks; * At least one measurable lesion per RECIST 1.1; * Adequate organ function Exclusion Criteria: * Specific anti-tumor treatment prior to 4 weeks; * more than 50% liver metastasis ; * Patient with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection etc; * History of severe hypersensitivity reaction to any monoclonal antibody or chemistry; * Women who are pregnant or in the period of lactation; * Patients with an active, known or suspected autoimmune disease. Patients are permitted to enrol if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement;
References
Publications (0)
Data not yet available