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A Study to Evaluate the Efficacy and Safety of Sintilimab in Combination With IBI305 (Anti-VEGF Monoclonal Antibody) Compared to Sorafenib as the First-Line Treatment for Advanced Hepatocellular Carcinoma.

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ClinicalTrials.gov Identifier: NCT03794440
Recruitment Status : Unknown
Verified May 2020 by Innovent Biologics (Suzhou) Co. Ltd..
Recruitment status was:  Active, not recruiting
First Posted : January 7, 2019
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Study Description
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Brief Summary:
The purpose of the study is to assess the safety, tolerability and effectiveness of Sintilimab in combination with IBI305 in patients with HCC as the first-line treatment compared with Sorafenib. This study is a randomised, Open-label，Multi-center Study. The primary endpoint is overall survival.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Sintilimab Drug: IBI305 Drug: Sorafenib Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 595 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label，Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Sintilimab and IBI305 Compared to Sorafenib in the First-Line Treatment of Patients With Advanced Hepatocellular Carcinoma. （ORIENT-32）
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sintilimab +IBI305 Drug: Sintilimab
200mg IV d1， Q3W
Other Name: IBI308

Drug: IBI305
15mg/kg IV d1， Q3W
Other Name: anti-VEGF monoclonal antibody
Active Comparator: Sorafenib Drug: Sorafenib
400mg PO BID


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: up to 24 months after randomization ]
  2. Progression-free survival (PFS) [ Time Frame: up to 24 months after randomization ]
    Progression-free survival (PFS) in two arms based on RECIST V1.1 by Independent Radiological Review Committee, IRRC.


Secondary Outcome Measures :
  1. PFS [ Time Frame: up to 24 months after randomization ]
    PFS in two arms based on RECIST V1.1 by investigator.

  2. Objective response rate (ORR) [ Time Frame: up to 24 months after randomization ]
    Objective response rate (ORR) in two arms based on RECIST V1.1 by IRRC and investigator .

  3. Disease control rate (DCR) [ Time Frame: up to 24 months after randomization ]
    DCR in two arms based on RECIST V1.1 by IRRC and investigator.

  4. Duration of response (DOR) [ Time Frame: up to 24 months after randomization ]
    DOR in two arms based on RECIST V1.1 by IRRC and investigator.

  5. Time to progression (TTP) [ Time Frame: One assessment was performed every 6 weeks (±7 days) from the time of randomization, and once every 12 weeks (±7 days) after 48 weeks. ]
    TTP in two arms based on RECIST V1.1 by IRRC and investigator.

  6. Time to response (TTR) [ Time Frame: up to 24 months after randomization ]
    TTR in two arms based on RECIST V1.1 by IRRC and investigator.

  7. PFS [ Time Frame: up to 24 months after randomization ]
    PFS in two arms based on mRECIST by IRRC.

  8. Objective response rate (ORR) [ Time Frame: up to 24 months after randomization ]
    Objective response rate (ORR) in two arms based on mRECIST by IRRC.

  9. Time to progression (TTP) [ Time Frame: up to 24 months after randomization ]
    TTP in two arms based on mRECIST by IRRC.

  10. Duration of response (DOR) [ Time Frame: up to 24 months after randomization ]
    DOR in two arms based on mRECIST by IRRC.

  11. Disease control rate (DCR) [ Time Frame: up to 24 months after randomization ]
    DCR in two arms based on mRECIST by IRRC.

  12. Time to response (TTR) [ Time Frame: up to 24 months after randomization ]
    TTR in two arms based on mRECIST by IRRC.

  13. Anti-drug antibody (ADA) [ Time Frame: up to 24 months after randomization ]
    Immunogenicity measured by anti-drug antibody (ADA) for Sintilimab and IBI305.

  14. EORTC QLQ-C30 [ Time Frame: up to 24 months after randomization ]
  15. EORTC QLQ-HCC18 [ Time Frame: up to 24 months after randomization ]

Eligibility Criteria
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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. Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD).
  2. ECOG performance status between 0 and 1
  3. No systematic anti-tumor treatment has been performed.(End of postoperative adjuvant chemotherapy for more than 6 months allowed).
  4. Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment.
  5. At least 1 lesion with measurable disease at baseline by RECIST V1.1.
  6. Child-Pugh: <=7
  7. Adequate organ and bone marrow function.

Exclusion Criteria:

  1. With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
  2. Have a history of hepatic encephalopathy or have a history of liver transplantation.
  3. With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
  4. Central nervous system (CNS) metastasis.
  5. Uncontrolled high blood pressure, systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg after optimal medical treatment.
  6. Local treatment for liver lesions within 4 weeks.
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): NCT03794440


Locations
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China, Shanghai
Hospital of Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT03794440    
Other Study ID Numbers: CIBI338B301
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: May 2020

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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
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action