Trials / Not Yet Recruiting
Not Yet RecruitingNCT05507632
Donafenib Plus Sintilimab in Combination With TACE in Patients With Unresectable Hepatocellular Carcinoma
A Prospective, Single-arm, Phase II Clinical Study of the Efficacy and Safety of Donafenib Plus Sintilimab Combined With Transarterial Chemoembolization (TACE) in Patients With BCLC Stage B/C Hepatocellular Carcinoma
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Nanfang Hospital, Southern Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy and safety of Donafenib plus Sintilimab in combination with transarterial chemoembolisation (TACE) in patients with unresectable hepatocellular carcinoma(HCC).
Detailed description
Transarterial chemoembolisation (TACE) was effective and safe for hepatocellular carcinoma. Donafenib was better than sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated TACE plus donafenib and sintilimab. Thus, the investigators carried out this prospective, single-arm study to find out it.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Donafenib plus Sintilimab in combination with transarterial chemoembolisation | Donafenib plus Sintilimab in combination with transarterial chemoembolisation (TACE) |
Timeline
- Start date
- 2022-08-15
- Primary completion
- 2024-12-31
- Completion
- 2026-12-21
- First posted
- 2022-08-19
- Last updated
- 2022-08-19
Source: ClinicalTrials.gov record NCT05507632. Inclusion in this directory is not an endorsement.