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NCT03779035: AdBTC-1
Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection
Phase 3 trial testing Gemcitabine in Cholangiocarcinoma in 460 participants. Status unknown.
31 December 2020
Quick facts
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 460 |
| Start date | 15 December 2018 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Gemcitabine (gemcitabine) — full drug profile →
- Capecitabine (capecitabine) — full drug profile →
Conditions studied
- Cholangiocarcinoma — all drugs for Cholangiocarcinoma →
- Gall Bladder Carcinoma — all drugs for Gall Bladder Carcinoma →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03779035
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Tianjin Medical University Cancer Institute and Hospital trials
Trials by the same sponsor.
- NCT07493993 — Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoa · Phase 2 · not yet recruiting
- NCT07515469 — A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD · Phase 2 · not yet recruiting
- NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
- NCT07510594 — A Phase II Study of Benmelstobart + Anlotinib + Chemotherapy as First-Line Treatment for LCNEC and EP-NEC · Phase 2 · not yet recruiting
- NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03779035 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tianjin Medical University Cancer Institute and Hospital
- Last refreshed: 19 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03779035.
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