Trials / Completed
CompletedNCT03764293
A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC
A Randomized, Open-Label, International, Multi-Center, Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Apatinib Mesylate Versus Sorafenib as First-Line Therapy in Patients With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Therapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 543 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced HCC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-1210 | Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial |
| DRUG | Apatinib | Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet |
| DRUG | Sorafenib | Subjects receive Sorafenib orally, Dosage form: tablet, Strength: 0.2 g/tablet |
Timeline
- Start date
- 2019-06-10
- Primary completion
- 2022-02-08
- Completion
- 2023-06-14
- First posted
- 2018-12-05
- Last updated
- 2024-02-06
- Results posted
- 2024-02-06
Locations
121 sites across 13 countries: United States, Belgium, China, Germany, Hong Kong, Italy, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03764293. Inclusion in this directory is not an endorsement.