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NCT06699459: NICRRBTC
Irinotecan Liposomes +5-FU/LV Versus Capecitabine in Patients of Recurrence After Resection of Resectable BTC
Phase 2 trial testing Irinotecan Liposome in Biliary Tract Carcinoma in 76 participants. Not yet recruiting.
15 November 2026
Quick facts
| Lead sponsor | Sir Run Run Shaw Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 76 |
| Start date | 14 November 2024 |
| Primary completion | 15 November 2026 |
| Estimated completion | 15 November 2026 |
| Sites | 6 locations across China |
Drugs / interventions tested
- Irinotecan Liposome
- Capecitabine (capecitabine) — full drug profile →
Conditions studied
- Biliary Tract Carcinoma — all drugs for Biliary Tract Carcinoma →
Sponsor
Sir Run Run Shaw Hospital
Who can join
Adults 18 to 75, any sex, with Biliary Tract Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Irinotecan liposome combined with 5-FU/LV has shown good efficacy and has certain advantages in reducing the adverse reactions of conventional chemotherapy drugs. Adjuvant treatment of high-risk factors after surgery for biliary tract tumors can be further explored and attempted. Therefore, this study intends to conduct an exploratory study comparing oral capecitabine with irinotecan liposome +5-FU/LV for adjuvant therapy in high-risk patients after resection of resectable biliary malignancies, and evaluate the effectiveness and safety of irinotecan liposome +5-FU/LV as adjuvant therapy for high-risk patients after resection of resectable biliary malignancies. So it can provide more treatment options for patients with postoperative adjuvant therapy of biliary tract malignant tumor. The DFS rate one year after surgery for biliary malignancy was assumed to be 51.4% with a maximum response rate of poor efficacy and 71.4% with a minimum response rate of good efficacy. A two-stage design was adopted with α=0.05 and certainty (1-β) =0.8, and Minimax was adopted. If a response occurs in 7 out of 14 patients or less, treatment options are rejected; In the second phase, if 24 or fewer responses occur in 38 patients, the protocol is rejected. A total of 38 samples were designed in two stages. The 1-year DFS rate was at least 65.8% in the total population of the test and control groups.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06699459
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Irinotecan Liposome
Trials testing the same drug.
- NCT06341309 — Exploratory Study of Irinotecan Liposomes in Maintenance Therapy of Metastatic Colorectal Cancer · Phase 1, PHASE2 · not yet recruiting
- NCT06443307 — Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan · recruiting
- NCT06258642 — Irinotecan Liposome Combined With Anlotinib as Second-line Regimen for SCLC · NA · recruiting
- NCT06225622 — Dose Escalation and Expansion Clinical Trial of Irinotecan Liposome Combined With Oxaliplatin and 5-FU/LV Plus Bevacizum · Phase 1 · recruiting
Other recruiting trials for Biliary Tract Carcinoma
Currently open trials in the same condition.
- NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
- NCT06168292 — Intraductal Radiofrequency Thermoablation and Radiotherapy Combined Treatment for Extrahepatic Cholangiocarcinoma · NA · recruiting
- NCT06349044 — A Randomized, Multicenter Phase II Basket Study of Hypofractionated Radiotherapy/Stereotactic Body Radiotherapy Followed · NA · recruiting
- NCT05668884 — GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma · Phase 2 · recruiting
- NCT05123482 — A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies · Phase 1, PHASE2 · recruiting
Other Sir Run Run Shaw Hospital trials
Trials by the same sponsor.
- NCT07453940 — Left Atrial Appendage Closure With Versus Without Pulsed Field Ablation in Atrial Fibrillation Patients With Mild Sympto · NA · recruiting
- NCT07508943 — Decision-making and Optimization of Ventilatory Support for AECOPD Patients · not yet recruiting
- NCT07514533 — The Efficacy and Safety of Pucotenlimab (PD-1) Combined With Becotatugvedotin (EGFR-ADC) in Advanced Cholangiocarcinoma · Phase 2 · not yet recruiting
- NCT07350590 — Comparison Between Robotic and Laparoscopic Right Hemicolectomy · terminated
- NCT07457073 — AI-Powered Sound Analysis for COPD Screening · active not 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 NCT06699459 (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 Sir Run Run Shaw Hospital
- Last refreshed: 21 November 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/NCT06699459.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing