Clinical trial · Observational
A Single Center Real-world Study of Donafenib in the Treatment of Hepatocellular Carcinoma in Routine Clinical Practice
A Single Center Real-world Study of Donafenib in the Treatment of Hepatocellular Carcinoma (HCC) in Routine Clinical Practice
NCT05200221CI-TRIAL-00057469unknownClinicalTrials.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 trial is a single center observational real-world study. It is planned to include 300 patients with unresectable hepatocellular carcinoma (uHCC) treated with Donafenib. The purpose of the study was to observe the effectiveness and safety of Donafenib in the real world.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Donafenib
- description
- Patients with uHCC taking donafenib in clinical treatment
Primary outcomes (1)
- measure
- Incidence of adverse events and serious adverse events.
- timeFrame
- an average of 1.5 year.
- description
- Incidence of adverse events and serious adverse events.
Secondary outcomes (5)
- measure
- Objective response rate (ORR)
- timeFrame
- an average of 1 year.
- description
- According to RECIST v1.1 and mRECIST to evaluate the proportion of patients with complete response(CR) and partial response(PR) in the total number of patients.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years old; 2. Histologically confirmed HCC or meet the clinical diagnostic criteria of HCC; 3. Unresectable HCC; 4. The doctor decided to use donafenib before the patient was enrolled in the study； 5. Informed consent and willing to complete the study according to the protocol. Exclusion Criteria: 1. Those who are participating in clinical trials of other antitumor drugs; 2. Allergic to any component of Donafenib tablets; 3. Patients with active bleeding, active peptic ulcer, drug uncontrollable hypertension or severe liver dysfunction; 4. Pregnant or lactating women.
References
Publications (0)
Data not yet available
No reference posted for this study.