A Study of Camrelizumab Combined With Rivoceranib Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC)

Hengrui Medicine

Status and phase: Terminated; Phase 3

Conditions: Advanced Hepatocellular Carcinoma (HCC)

Treatments: Drug: camrelizumab；Rivoceranib; Drug: Rivoceranib; Drug: Regorafenib; Drug: Sorafenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04985136

SHR-1210-III-330

Details and patient eligibility

About

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)

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject must participate voluntarily and sign the informed consent form;
2. Aged ≥ 18 years old, male or female;
3. Histopathologically confirmed hepatocellular carcinoma;
4. Has PD on treatment with prior anti-PD-1/PD-L1/CTLA-4 monoclonal antibody (mAb) administered either as monotherapy or as combination therapy.
5. No more than 2 lines of previous system treatment;
6. Be able to provide fresh or archived tumor tissue samples;
7. Patient with at least one measurable lesion (for Stage I);
8. Barcelona clinic liver cancer: Stage B or C;
9. Child-Pugh score: ≤ 7;
10. ECOG PS score of 0-1;
11. Life expectancy of ≥ 12 weeks;
12. Adequate organ function
13. Must take one medically approved contraceptive measure

Exclusion criteria

1. Patients with any active, known or suspected autoimmune disorder;
2. Patients who have used corticosteroids or other immunosuppressive agents for systemic treatment within 1 month prior to randomization;
3. With known severe allergic reactions to any other monoclonal antibodies;
4. Received previous camrelizumab or rivoceranib mesylate treatment;
5. Patients who discontinued ICIs treatment due to immune-related toxicity;
6. Patients with known CNS metastasis or hepatic encephalopathy;
7. Patients with liver tumor burden greater than 50% of total liver in volume, or patients who have previously undergone liver transplantation;;
8. Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before randomization;
9. Patients with other malignancies currently or within the past 5 years;
10. Patients with hypertension which cannot be well controlled by antihypertensives; history of hypertensive crisis or hypertensive encephalopathy;
11. Uncontrolled cardiac diseases or symptoms；
12. Known hereditary or acquired bleeding disorders;
13. Clinically significant bleeding symptoms or clear bleeding tendency;
14. Patients with gastrointestinal perforation or gastrointestinal fistula;
15. Patients with significant vascular invasions with a high possibility of fatal bleeding;
16. Patients with important arterial/venous thrombosis;
17. Patients experiencing toxicity caused by previous anti-tumor therapy that has not recovered to Grade ≤ 1;
18. Patients with active infection;
19. Patients with congenital or acquired immune deficiency;
20. Patients who received live vaccines within 28 days prior to randomization, or are expect to be vaccinated during the treatment period;
21. Patients with other potential factors that may affect the study results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 4 patient groups

camrelizumab + Rivoceranib

Experimental group

Treatment:

Drug: camrelizumab；Rivoceranib

Rivoceranib

Active Comparator group

Treatment:

Drug: Rivoceranib

Sorafenib

Active Comparator group

Treatment:

Drug: Sorafenib

Regorafenib

Active Comparator group

Treatment:

Drug: Regorafenib