deltatrials
Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT03478488

Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC (KN035-BTC)

Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer: a Randomised, Open-label, Parallel-group, Multicenter Phase III Study

Sponsor: 3D Medicines (Sichuan) Co., Ltd.

Conditions Biliary Tract Neoplasms
Interventions Gemcitabine & oxaliplatin KN035 plus Gemcitabine & oxaliplatin
Updated 14 times since 2018 Last updated: May 27, 2025 Started: Apr 16, 2018 Primary completion: Sep 10, 2024 Completion: Dec 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Biliary Tract Neoplasms and is currently ongoing. 3D Medicines (Sichuan) Co., Ltd. leads this study, which shows 14 recorded versions since 2018 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jan 2020 · 19 months · monthly snapshot~Jan 2020 – ~Jan 2021 · 12 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Apr 2022 · 12 months · monthly snapshot~Apr 2022 – ~Jul 2022 · 3 months · monthly snapshot~Jul 2022 – ~May 2023 · 10 months · monthly snapshot~May 2023 – ~Feb 2024 · 9 months · monthly snapshot~Feb 2024 – ~Jun 2024 · 4 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jun 2025 · 9 months · monthly snapshot~Jun 2025 – present · 13 months · monthly snapshot

Change History

14 versions recorded

  1. Jun 2025 — Present [monthly]

    Active Not Recruiting PHASE3

  2. Sep 2024 — Jun 2025 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  3. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

  4. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

  5. Feb 2024 — Jun 2024 [monthly]

    Recruiting PHASE3

▶ Show 9 earlier versions

  1. May 2023 — Feb 2024 [monthly]

    Recruiting PHASE3

  2. Jul 2022 — May 2023 [monthly]

    Recruiting PHASE3

  3. Apr 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  4. Apr 2021 — Apr 2022 [monthly]

    Recruiting PHASE3

  5. Jan 2021 — Apr 2021 [monthly]

    Recruiting PHASE3

  6. Jan 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  7. Jun 2018 — Jan 2020 [monthly]

    Not Yet Recruiting PHASE3

  8. May 2018 — Jun 2018 [monthly]

    Not Yet Recruiting PHASE3

  9. Apr 2018 — May 2018 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • 3D Medicines (Sichuan) Co., Ltd.
Data source: 3D Medicines

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations