A Phase 3 interventional study of KN035 plus Gemcitabine & oxaliplatin and Gemcitabine & oxaliplatin in Biliary Tract Neoplasms, sponsored by 3D Medicines (Sichuan) Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by 3D Medicines (Sichuan) Co., Ltd. · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Drug: KN035 plus Gemcitabine & oxaliplatin
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.
Drug: Gemcitabine & oxaliplatin
KN035 a programmed death ligand immune check inhibitor Per Investigator decision
Also known as: Experimental
The standard of care for the patients with unresectable/metastatic biliary tract cancer
Also known as: Active Comparator
Overall Survival (OS)
was defined as the time from randomization to death due to any cause.
Time frame: Observed by 12 weeks after progressive disease or end of treatment
Progression Free Survival (PFS)
was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent Review Committee (BIRC) review.
Time frame: Observed by 6 weeks
Objective response rate (ORR)
was defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on BIRC evaluation.
Time frame: Observed by 6 weeks
Disease control rate (DCR)
was defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response or stable disease and was assessed using RECIST 1.1 based on BIRC evaluation
Time frame: Observed by 6 weeks
Duration of Response (DOR)
was defined as the time from the first met for complete response/partial response (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study)
Time frame: Observed by 6 weeks
Time to progression (TTP)
was defined as the time from randomization to the first date that progressive disease was objectively documented
Time frame: Observed by 6 weeks
Plan to share: Undecided
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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3D Medicines (Sichuan) Co., Ltd.