A Study of Camrelizumab Combined With Rivoceranib Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC)
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: camrelizumab + Rivoceranib
|
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)
|
| Active Comparator: Rivoceranib
|
Drug: Rivoceranib
Rivoceranib mesylate (750 mg, QD, po)
|
| Active Comparator: Sorafenib
|
Drug: Sorafenib
Sorafenib tosylate (400 mg, twice a day (BID), po)
|
| Active Comparator: Regorafenib
|
Drug: Regorafenib
Regorafenib (160 mg, administer for 21 days then stop for 7 days, po)
|
Outcome Measures
Primary Outcome Measures
- Stage I：Objective Response Rate（ORR） [2.5 years]
- Stage II：Overall survival （OS） [2.5 years]
Secondary Outcome Measures
- Stage I：Overall survival （OS） [2.5 years]
- Adverse Events（AEs） [2.5 years]
- Stage II：Objective Response Rate（ORR） [2.5 years]
- Disease Control Rate（DCR） [2.5 years]
- Duration of Response（DoR） [2.5 years]
- Progression-Free-Survival （PFS） [2.5 years]
- time to progression （TTP） [2.5 years]
- Pharmacokinetics (PK) Ctrough of camrelizumab [2.5 years]
- Pharmacokinetics (PK) Ctrough of Apatinib [2.5 years]
- Proportion of anti- camrelizumab antibody (ADA) [2.5 years]
- Proportion of neutralizing antibody (Nab) [2.5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject must participate voluntarily and sign the informed consent form;
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Aged ≥ 18 years old, male or female;
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Histopathologically confirmed hepatocellular carcinoma;
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Has PD on treatment with prior anti-PD-1/PD-L1/CTLA-4 monoclonal antibody (mAb) administered either as monotherapy or as combination therapy.
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No more than 2 lines of previous system treatment;
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Be able to provide fresh or archived tumor tissue samples;
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Patient with at least one measurable lesion (for Stage I);
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Barcelona clinic liver cancer: Stage B or C;
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Child-Pugh score: ≤ 7;
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ECOG PS score of 0-1;
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Life expectancy of ≥ 12 weeks;
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Adequate organ function
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Must take one medically approved contraceptive measure
Exclusion Criteria:
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Patients with any active, known or suspected autoimmune disorder;
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Patients who have used corticosteroids or other immunosuppressive agents for systemic treatment within 1 month prior to randomization;
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With known severe allergic reactions to any other monoclonal antibodies;
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Received previous camrelizumab or rivoceranib mesylate treatment;
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Patients who discontinued ICIs treatment due to immune-related toxicity;
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Patients with known CNS metastasis or hepatic encephalopathy;
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Patients with liver tumor burden greater than 50% of total liver in volume, or patients who have previously undergone liver transplantation;;
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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;
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Patients with other malignancies currently or within the past 5 years;
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Patients with hypertension which cannot be well controlled by antihypertensives; history of hypertensive crisis or hypertensive encephalopathy;
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Uncontrolled cardiac diseases or symptoms；
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Known hereditary or acquired bleeding disorders;
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Clinically significant bleeding symptoms or clear bleeding tendency;
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Patients with gastrointestinal perforation or gastrointestinal fistula;
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Patients with significant vascular invasions with a high possibility of fatal bleeding;
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Patients with important arterial/venous thrombosis;
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Patients experiencing toxicity caused by previous anti-tumor therapy that has not recovered to Grade ≤ 1;
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Patients with active infection;
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Patients with congenital or acquired immune deficiency;
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Patients who received live vaccines within 28 days prior to randomization, or are expect to be vaccinated during the treatment period;
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Patients with other potential factors that may affect the study results.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chinese PLA General Hospital | Beijing | Beijing | China | 100853 |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR-1210-III-330