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

NCT04985136 | Terminated Phase 3

• 1 other identifier: SHR-1210-III-330
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• Stage I：Objective Response Rate（ORR）

  2.5 years

• Stage II：Overall survival （OS）

  2.5 years

Secondary Outcomes (11)

• 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

Study Arms (4)

camrelizumab + Rivoceranib

EXPERIMENTAL

Drug: camrelizumab；Rivoceranib

Rivoceranib

ACTIVE COMPARATOR

Drug: Rivoceranib

Sorafenib

ACTIVE COMPARATOR

Drug: Sorafenib

Regorafenib

ACTIVE COMPARATOR

Drug: Regorafenib

Interventions

camrelizumab；Rivoceranib 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)

camrelizumab + Rivoceranib

Rivoceranib DRUG

Rivoceranib mesylate (750 mg, QD, po)

Rivoceranib

Sorafenib DRUG

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

Sorafenib

Regorafenib DRUG

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

Regorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with any active, known or suspected autoimmune disorder;
• Patients who have used corticosteroids or other immunosuppressive agents for systemic treatment within 1 month prior to randomization;
• With known severe allergic reactions to any other monoclonal antibodies;
• Received previous camrelizumab or rivoceranib mesylate treatment;
• Patients who discontinued ICIs treatment due to immune-related toxicity;
• Patients with known CNS metastasis or hepatic encephalopathy;
• Patients with liver tumor burden greater than 50% of total liver in volume, or patients who have previously undergone liver transplantation;;
• 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;
• Patients with other malignancies currently or within the past 5 years;
• Patients with hypertension which cannot be well controlled by antihypertensives; history of hypertensive crisis or hypertensive encephalopathy;
• Uncontrolled cardiac diseases or symptoms；
• Known hereditary or acquired bleeding disorders;
• Clinically significant bleeding symptoms or clear bleeding tendency;
• Patients with gastrointestinal perforation or gastrointestinal fistula;
• Patients with significant vascular invasions with a high possibility of fatal bleeding;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Interventions

apatinib; Sorafenib; regorafenib

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized，Open，Controlled, International Multi-Center

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 2, 2021
• Study Start: September 26, 2021
• Primary Completion: December 29, 2021
• Study Completion: December 29, 2021
• Last Updated: September 1, 2022

Record last verified: 2021-07

Locations

CN (1)