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

Advanced Hepatocellular Carcinoma (HCC) Clinical Trial

Official title:

A Randomized, Open-Label, Controlled, International Multi-Center Phase III Clinical Study of Camrelizumab Combined With Rivoceranib (Apatinib) Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Hepatocellular Carcinoma (HCC) Who Have Been Treated With Immune Checkpoint Inhibitors (ICIs)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04985136
• Other study ID #: SHR-1210-III-330
• Status: Terminated
• Phase: Phase 3
• Start date: September 26, 2021
• Est. completion date: December 29, 2021

Study information

• Verified date: July 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 29, 2021
• Est. primary completion date: December 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma (HCC)
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• 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)
• Rivoceranib
Rivoceranib mesylate (750 mg, QD, po)
• Sorafenib
Sorafenib tosylate (400 mg, twice a day (BID), po)
• Regorafenib
Regorafenib (160 mg, administer for 21 days then stop for 7 days, po)

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stage I:Objective Response Rate(ORR)		2.5 years
Primary	Stage II:Overall survival (OS)		2.5 years
Secondary	Stage I:Overall survival (OS)		2.5 years
Secondary	Adverse Events(AEs)		2.5 years
Secondary	Stage II:Objective Response Rate(ORR)		2.5 years
Secondary	Disease Control Rate(DCR)		2.5 years
Secondary	Duration of Response(DoR)		2.5 years
Secondary	Progression-Free-Survival (PFS)		2.5 years
Secondary	time to progression (TTP)		2.5 years
Secondary	Pharmacokinetics (PK) Ctrough of camrelizumab		2.5 years
Secondary	Pharmacokinetics (PK) Ctrough of Apatinib		2.5 years
Secondary	Proportion of anti- camrelizumab antibody (ADA)		2.5 years
Secondary	Proportion of neutralizing antibody (Nab)		2.5 years