Clinical trial · Observational
A Real-world Study of Donafenib Combined With TACE-based Treatment in Patients With Unresectable HCC
A Real-world Clinical Study of Donafenib Combined With TACE as a Basis for the Treatment of Unresectable Hepatocellular Carcinoma
NCT05205629CI-TRIAL-00057282unknownClinicalTrials.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 is a prospective, single-center, observational real-world study. It is planned to enroll 150 patients with unresectable hepatocellular carcinoma treated with Donafenib combined with TACE-based treatment, so as to observe and evaluate the efficacy and safety of Donafenib combined with TACE-based treatment in patients with unresectable HCC.
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 |
|---|---|---|---|
| Donafenib | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donafenib combined with TACE | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Donafenib + TACE
- interventionNames
- Drug: Donafenib combined with TACE
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- an expected average of 8 months
- description
- Defined as the time from the start of enrollment to the occurrence of disease progression that cannot be treated by TACE or death due to various reasons.
Secondary outcomes (6)
- measure
- Objective response rate
- timeFrame
- an expected average of 12 months
- description
- evaluated by investigators with mRECIST
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients voluntarily entered the study and signed informed consent form (ICF); 2. Age: Be at least 18 years old and and there is no limit on the gender; 3. Clinically or histologically diagnosed as unresectable HCC; 4. There is at least one measurable lesions that meet the mRECIST standard; 5. Child-pugh classification A or B (score≤7); 6. The maximum number of TACE procedures allowed before enrolment was 2. All of those patients who had a history of prior TACE achieved complete response by previous TACE, but recurred more than 6 months later at the study entry 7. ECOG : 0 \~ 2 ; 8. Before the patients were enrolled in the study, doctors had decided to treat them with donafenib in combination with TACE. Exclusion Criteria: 1. Donafenib forbidden population: * Those who are allergic to any component of the medicine; * Active bleeding; * Active peptic ulcer; * Hypertension not controlled by drugs; * Those with severe liver insufficiency. 2. Medical conditions that affect absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.); 3. Patients with a clear past history of neurological or psychiatric disorders; 4. The patient had been treated with another study drug or study device in the 4 weeks prior to initial dosing; 5. Pregnant or breastfeeding women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures; 6. Unable to follow the research protocol for treatment or scheduled follow-up; 7. Any other researcher who thinks they cannot be included.
References
Publications (0)
Data not yet available
No reference posted for this study.