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

• Status: Enrolling by invitation
• Trial end date: 2024-03-30
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Apatinib; Sorafenib

Criteria

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.