Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC

Study acronym: KN035-BTC
StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Trial completed Show 6 more changesShow less
    • Study completion date changed from estimate of Dec 31, 2026 to Sep 10, 2024
    • Enrollment target: estimated 480 to confirmed 472
    • Interventions: Gemcitabine & oxaliplatin (Drug), KN035 plus Gemcitabine & oxaliplatin (Drug) to Gemcitabine & oxaliplatin (Drug), KN035 plus Gemcitabine & oxaliplatin (Drug)
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site details revised
  2. Primary completion date changed from estimate of Jan 15, 2025 to Sep 10, 2024
    • Study completion date: Jan 31, 2025 to Dec 31, 2026
    v13
  3. Primary completion date: Jul 15, 2024 to Jan 15, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jul 30, 2024 to Jan 31, 2025
    • Site details revised
    v12
  4. Primary completion date: Jan 31, 2024 to Jul 15, 2024v11
  5. 3 versions Re-verified since Jun 19, 2022, no change to tracked fieldsv8-v10
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v7
  2. Primary completion date: Dec 31, 2021 to Jan 31, 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 30, 2022 to Jul 30, 2024
    • Site details revised
    v6
  3. Enrollment target: 390 to 480v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 31, 2018 to Apr 16, 2018
    • Site details revised
    v4
  5. Secondary endpoints: details revised at 1 of 5 entriesv3
  6. Interventions: Gemcitabine & oxaliplatin (Drug), KN035&Gemcitabine & oxaliplatin (Drug) to Gemcitabine & oxaliplatin (Drug), KN035 plus Gemcitabine & oxaliplatin (Drug)
    • Secondary endpoints: details revised at 1 of 5 entries
    • Eligibility criteria expanded, about 1 word
    • Study title expanded, about 3 words
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03478488
Lead Sponsor 3D Medicines (Sichuan) Co., Ltd.
Conditions
(from sponsor)		 Biliary Tract Neoplasms
Related terms Biliary Tract Neoplasms
Enrollment 472 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov