Trials / Unknown
UnknownNCT04605185
Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma
Dose Escalation Study Of Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is the single-center, open-label phase I clinical trial to evaluate tolerability, safety and efficacy of Donafenib and JS001 in combination with TCAE in patients with Unresectable Hepatocellular Carcinoma.
Detailed description
The phase I clinical trial is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of Donafenib in this regimen, and select an acceptable safe dose for the phase II clinical trial(RP2D).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Donafenib Tosilate Tablets | 100mg Qd/150mg Qd/100mg Bid, po |
| BIOLOGICAL | Toripalimab Injection | 240 mg, iv drip,q3w |
Timeline
- Start date
- 2021-01-08
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2020-10-27
- Last updated
- 2024-03-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04605185. Inclusion in this directory is not an endorsement.