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Trial record 2 of 4 for:    Rivoceranib | Phase 3
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A Study of Camrelizumab Combined With Rivoceranib Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04985136
Recruitment Status : Terminated (Sponsor R & D Strategy Adjustment)
First Posted : August 2, 2021
Last Update Posted : September 1, 2022
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
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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
Advanced Hepatocellular Carcinoma (HCC) Drug: camrelizumab；Rivoceranib Drug: Rivoceranib Drug: Sorafenib Drug: Regorafenib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized，Open，Controlled, International Multi-Center
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 26, 2021
Actual Primary Completion Date : December 29, 2021
Actual Study Completion Date : December 29, 2021
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Stage I：Objective Response Rate（ORR） [ Time Frame: 2.5 years ]
  2. Stage II：Overall survival （OS） [ Time Frame: 2.5 years ]

Secondary Outcome Measures :
  1. Stage I：Overall survival （OS） [ Time Frame: 2.5 years ]
  2. Adverse Events（AEs） [ Time Frame: 2.5 years ]
  3. Stage II：Objective Response Rate（ORR） [ Time Frame: 2.5 years ]
  4. Disease Control Rate（DCR） [ Time Frame: 2.5 years ]
  5. Duration of Response（DoR） [ Time Frame: 2.5 years ]
  6. Progression-Free-Survival （PFS） [ Time Frame: 2.5 years ]
  7. time to progression （TTP） [ Time Frame: 2.5 years ]
  8. Pharmacokinetics (PK) Ctrough of camrelizumab [ Time Frame: 2.5 years ]
  9. Pharmacokinetics (PK) Ctrough of Apatinib [ Time Frame: 2.5 years ]
  10. Proportion of anti- camrelizumab antibody (ADA) [ Time Frame: 2.5 years ]
  11. Proportion of neutralizing antibody (Nab) [ Time Frame: 2.5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04985136


Locations
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China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
More Information
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04985136    
Other Study ID Numbers: SHR-1210-III-330
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: September 1, 2022
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Liver Diseases
Sorafenib
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action