Clinical trial · Interventional
Donafenib Plus Sintilimab for Advanced HCC
Donafenib Combined With Sintilimab for Advanced HCC: a Single-arm, Single-center, Prospective Study
NCT05162352CI-TRIAL-00085904completedPhase 2ClinicalTrials.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 will evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced hepatocellullar carcinoma (HCC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donafenib+sintilimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Donafenib+sintilimab
- description
- Donafenib combined with sitilimab.
- interventionNames
- Drug: Donafenib+sintilimab
Primary outcomes (1)
- measure
- Progression free survival (PFS) assessed by investigators according to modified Response Evalutaion Criteria in Solid Tumors (mRECIST).
- timeFrame
- 18 months
- description
- The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Secondary outcomes (6)
- measure
- Adverse Events (AEs)
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced HCC (BCLC stage C or CNLC IIIa/IIIb ) with diagnosis confirmed by histology/cytology or clinically * Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included * Patients who previously received local treatment, such as transcatheter arterial chemoembolization, transcatheter arterial embolization and radiotherapy, are allowed to be included * At least one measurable lesion * Child-Pugh score ≤7 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ and hematologic function * Life expectancy of at least 3 months Exclusion Criteria: * Diffuse HCC * Macrovascular invasion involving the main trunk or inferior vena cava * Central nervous system metastasis * History of malignancy other than HCC * Esophageal and/or gastric varices bleeding within 3 months prior to initiation of study treatment * Uncontrolled ascites * History of hepatic encephalopathy * Patients who received prior systemic therapy (chemotherapy, targeted therapy or immunotherapy) or hepatic arterial infusion chemotherapy (HAIC) for HCC * History of organ and cell transplantation * Active severe infection; use of antibiotics within 2 weeks prior to injection of sintilimab * Autoimmune disease or immune deficiency * Severe organ (heart, kidney) dysfunction
References
Publications (1)
- DERIVEDHong X, Guo Y, Shi W, Zhu K, Liang L, Lin L, Chen Y, Zhou J, Huang J, Huang J, Wu Y, Huang W, Cai M. Donafenib combined with sintilimab for advanced hepatocellular carcinoma: a single arm phase II trial. BMC Cancer. 2025 Feb 5;25(1):205. doi: 10.1186/s12885-025-13605-2. PMID 39910472