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NCT03779035: AdBTC-1

Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection

Status unknown Phase 3 Last updated 19 December 2018
What this trial tests

Phase 3 trial testing Gemcitabine in Cholangiocarcinoma in 460 participants. Status unknown.

Timeline
15 December 2018
Primary endpoint
31 December 2020
31 December 2023

Quick facts

Lead sponsorTianjin Medical University Cancer Institute and Hospital
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment460
Start date15 December 2018
Primary completion31 December 2020
Estimated completion31 December 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Who can join

18 and older, any sex, with Cholangiocarcinoma or Gall Bladder Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This prospective, open-Label, comparative, randomized, controlled phase III trial was designed to compare the clinical performance of gemcitabine with capecitabine vs. capecitabine alone for patients with biliary tract cancer (BTC) after curative resection.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Therapy of Primary Liver Cancer.
    Feng M, Pan Y, Kong R, Shu S. · · 2020 · cited 71× · PMID 32914142 · DOI 10.1016/j.xinn.2020.100032
  2. Gallbladder cancer: current and future treatment options.
    Zhou Y, Yuan K, Yang Y, Ji Z, et al · · 2023 · cited 40× · PMID 37251319 · DOI 10.3389/fphar.2023.1183619
  3. Chemotherapy for Biliary Tract Cancer in 2021.
    Sasaki T, Takeda T, Okamoto T, Ozaka M, et al · · 2021 · cited 39× · PMID 34300274 · DOI 10.3390/jcm10143108
  4. Gallbladder Cancer: Current Multimodality Treatment Concepts and Future Directions.
    Sturm N, Schuhbaur JS, Hüttner F, Perkhofer L, et al · · 2022 · cited 32× · PMID 36428670 · DOI 10.3390/cancers14225580
  5. Current progress in perioperative chemotherapy for biliary tract cancer.
    Ioka T, Shindo Y, Ueno M, Nagano H. · · 2023 · cited 21× · PMID 37416744 · DOI 10.1002/ags3.12691
  6. Adjuvant therapy of biliary tract cancers.
    Kefas J, Bridgewater J, Vogel A, Stein A, et al · · 2023 · cited 16× · PMID 37007632 · DOI 10.1177/17588359231163785
  7. Evolving Paradigms in the Systemic Treatment of Advanced Gallbladder Cancer: Updates in Year 2022.
    Hu ZI, Lim KH. · · 2022 · cited 13× · PMID 35267556 · DOI 10.3390/cancers14051249
  8. Current and Emerging Therapeutic Targets for the Treatment of Cholangiocarcinoma: An Updated Review.
    Hadfield MJ, DeCarli K, Bash K, Sun G, et al · · 2023 · cited 12× · PMID 38203714 · DOI 10.3390/ijms25010543

Verify or expand the search:

Other trials of Gemcitabine

Trials testing the same drug.

Other recruiting trials for Cholangiocarcinoma

Currently open trials in the same condition.

Other Tianjin Medical University Cancer Institute and Hospital trials

Trials by the same sponsor.

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