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NCT06812039
HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence
Phase 2 trial testing HAIC combined with sintilimab and donafenib in Hepato Cellular Carcinoma (HCC) in 165 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 165 |
| Start date | 1 January 2025 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 January 2028 |
| Sites | 3 locations across China |
Drugs / interventions tested
- HAIC combined with sintilimab and donafenib — full drug profile →
- Sintilimab and Donafenib — full drug profile →
- Surgery
Conditions studied
- Hepato Cellular Carcinoma (HCC) — all drugs for Hepato Cellular Carcinoma (HCC) →
Sponsor
Fudan University
Who can join
Adults 18 to 75, any sex, with Hepato Cellular Carcinoma (HCC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will evaluate the efficacy and safety of therapy perioperative treatment with HAIC combined with donafenib and sintilimab (group A)/ donafenib combined with sintilimab (group B) compared with direct surgery (group C) in resectable HCC patients who are at high risk for disease recurrence.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06812039
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hepato Cellular Carcinoma (HCC)
Currently open trials in the same condition.
- NCT07276100 — Fecal Microbiota Transplantation to RESCUE Patients With Unresectable Hcc Progressors to First Line Therapy With Atezoli · Phase 2 · recruiting
- NCT06990659 — Outpatient Versus Inpatient Care Pathway for Intra-arterial Treatment of Primary Liver Cancer (CHOC) · NA · recruiting
- NCT06960863 — Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma · recruiting
- NCT06960954 — PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma · recruiting
- NCT06742424 — PD-L1 Antibody + Bevacizumab With Hepatic Arterial Infusion Chemotherapy for Advanced HCC · Phase 2 · recruiting
Other Fudan University trials
Trials by the same sponsor.
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- NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · not yet 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 NCT06812039 (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 Fudan University
- Last refreshed: 6 February 2025
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/NCT06812039.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing