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

NCT ID: NCT04985136

Last Updated: 2022-09-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-26
• Study Completion Date: 2021-12-29

Brief 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)

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

camrelizumab + Rivoceranib

Group Type: EXPERIMENTAL

camrelizumab；Rivoceranib

Intervention Type: DRUG

Camrelizumab 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

Group Type: ACTIVE_COMPARATOR

Rivoceranib

Intervention Type: DRUG

Rivoceranib mesylate (750 mg, QD, po)

Sorafenib

Group Type: ACTIVE_COMPARATOR

Sorafenib

Intervention Type: DRUG

Sorafenib tosylate (400 mg, twice a day (BID), po)

Regorafenib

Group Type: ACTIVE_COMPARATOR

Regorafenib

Intervention Type: DRUG

Regorafenib (160 mg, administer for 21 days then stop for 7 days, po)

Interventions

camrelizumab；Rivoceranib

Camrelizumab 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)

Intervention Type: DRUG

Rivoceranib

Rivoceranib mesylate (750 mg, QD, po)

Intervention Type: DRUG

Sorafenib

Sorafenib tosylate (400 mg, twice a day (BID), po)

Intervention Type: DRUG

Regorafenib

Regorafenib (160 mg, administer for 21 days then stop for 7 days, po)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

SHR-1210-III-330

Identifier Type: -

Identifier Source: org_study_id