Clinical trial · Interventional
Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma
Efficacy and Safety of Donafenib as Adjuvant Therapy for Postoperative Patients With High-Risk Recurrent Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Study
NCT06581315CI-TRIAL-00080386recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate the efficacy and safety of donafenib as adjuvant therapy for postoperative patients with high-risk recurrent Hepatocellular Carcinoma. This is a multicenter, randomized controlled study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Therapy | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donafenib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (Donafenib)
- description
- Participants will receive Donafenib treatment until disease recurrence or unacceptable toxicity or up to 1 years.
- interventionNames
- Drug: Donafenib
- type
- NO_INTERVENTION
- label
- Arm B (active surveillance)
- description
- Active surveillance of participants.
Primary outcomes (1)
- measure
- One year recurrence-free survival (RFS) rate
- timeFrame
- 1 year
- description
- The proportion from randomization to 1 year without recurrence.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Participants underwent radical resection of hepatocellular carcinoma 4 weeks before randomization * High Risk of recurrence as assessed by tumor characteristics * Without any anti-tumor therapy before surgery, except preoperative TACE therapy, traditional Chinese medicine therapy and interferon therapy * Child-Pugh Class A statu * ECOG Performance Status of 0 or 1 * CT/MR confirmed no recurrence or metastasis at ≥4 weeks after surgery * Expected survival time of no less than 3 months Exclusion Criteria: * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC * Evidence of residual or a history of spontaneous tumor rupture * Recurrent HCC * Prior received Liver transplantation * Prior anti tumor therapy for treatment of HCC (including sorafenib or any other molecular therapy, anti-PD-1 antibody and other immunotherapies, FOLFOX systemic chemotherapy) is excluded * AFP does not return to normal 4 weeks after operation
References
Publications (0)
Data not yet available
No reference posted for this study.