A Study of Camrelizumab Combined With Rivoceranib Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Study ID
- NCT04985136
- Phase
- PHASE3
- Status
- Terminated
Conditions
- Advanced Hepatocellular Carcinoma (HCC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- camrelizumab；Rivoceranib — DRUGCamrelizumab at 200 mg via intravenous administration (IV), once every 2 weeks (Q2W), in combination with 250 mg of rivoceranib mesylate, oral administration, once a day (QD)
- Rivoceranib — DRUGRivoceranib mesylate (750 mg, QD, po)
- Sorafenib — DRUGSorafenib tosylate (400 mg, twice a day (BID), po)
- Regorafenib — DRUGRegorafenib (160 mg, administer for 21 days then stop for 7 days, po)
Study Details
This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of Camrelizumab Combined with Rivoceranib Mesylate versus Investigator's Choice of Regimen in Treatment of Patients with Hepatocellular Carcinoma (HCC)
Key Dates
- Start date
- Sep 26, 2021
- Status verified
- Jul 2021
- Primary completion
- Dec 29, 2021
- Completion
- Dec 29, 2021
Study Design
- Enrollment
- 1 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: camrelizumab + Rivoceranib
- Active Comparator: Rivoceranib
- Active Comparator: Sorafenib
- Active Comparator: Regorafenib
Primary Outcome Measure
Stage I：Objective Response Rate（ORR） [ Time Frame: 2.5 years ]