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NCT06282120
Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer
trial testing Irinotecan Hydrochloride Liposome Injection ；Fluorouracil ；Leucovorin；immunotherapy in Metastatic Biliary Tract Cancer in 30 participants. Status unknown.
5 January 2025
Quick facts
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 1 January 2024 |
| Primary completion | 5 January 2025 |
| Estimated completion | 1 January 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Irinotecan Hydrochloride Liposome Injection ；Fluorouracil ；Leucovorin；immunotherapy — full drug profile →
Conditions studied
- Metastatic Biliary Tract Cancer — all drugs for Metastatic Biliary Tract Cancer →
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Who can join
Adults 18 to 75, any sex, with Metastatic Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to test in biliary tract cancer patients . The main questions it aims to answer are: * To evaluate the efficacy of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer * To evaluate the safety of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer This study intends to use liposomal irinotecan combined with 5-FU/LV± immunotherapy for second-line treatment of advanced biliary tract cancer that has progressed after gemsitabine + immunotherapy to evaluate the efficacy and safety of this regimen, with a view to providing better treatment options for second-line patients with advanced biliary tract cancer.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06282120
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Metastatic Biliary Tract Cancer
Currently open trials in the same condition.
- NCT07107750 — Emavusertib (CA-4948) in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or · Phase 1 · recruiting
- NCT06548412 — CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Bi · Phase 1, PHASE2 · recruiting
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 NCT06282120 (US National Library of Medicine, public domain)
- 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: 28 February 2024
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/NCT06282120.
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