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NCT05640791
Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer
Phase 2 trial testing Cisplatin in Resectable Biliary Tract Cancer in 40 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 December 2022 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Cisplatin (cisplatin) — full drug profile →
- Gemcitabine (gemcitabine) — full drug profile →
- Nab-paclitaxel (nab-paclitaxel) — full drug profile →
- Durvalumab — full drug profile →
Conditions studied
- Resectable Biliary Tract Cancer — all drugs for Resectable Biliary Tract Cancer →
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Who can join
Adults 18 to 75, any sex, with Resectable Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase II trial studies how well gemcitabine, cisplatin, nab-paclitaxel and durvalumab work before surgery in treating participants with Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring survival benefits to advanced BTC. Drugs used in chemotherapy, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy and Durvalumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Design of studies on neoadjuvant therapy for intrahepatic cholangiocarcinoma.
Cheng Y, Li X. · · 2025 · cited 2× · PMID 39897772 · DOI 10.1016/j.heliyon.2024.e41356 -
Immune-Checkpoint Inhibitors for Biliary Tract Cancer: Who Benefits and What Is Next?
Ceniceros L, Torre M, Landa Magdalena A, Sangro P, et al · · 2025 · cited 1× · PMID 40940908 · DOI 10.3390/cancers17172811 -
Macrophage-rich niches regulate T cell dynamics at the liver invasive margin during gallbladder cancer progression
Li M, Liu Z, Shan S, Jia Z, et al ·
Verify or expand the search:
- PubMed search for NCT05640791
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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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 NCT05640791 (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: 7 December 2022
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/NCT05640791.
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