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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.

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sintilimab
IBI305
Sorafenib
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sintilimab +IBI305

Sorafenib

Arm Description

Outcomes

Primary Outcome Measures

Overall survival (OS)
Progression-free survival (PFS)
Progression-free survival (PFS) in two arms based on RECIST V1.1 by Independent Radiological Review Committee, IRRC.

Secondary Outcome Measures

PFS
PFS in two arms based on RECIST V1.1 by investigator.
Objective response rate (ORR)
Objective response rate (ORR) in two arms based on RECIST V1.1 by IRRC and investigator .
Disease control rate (DCR)
DCR in two arms based on RECIST V1.1 by IRRC and investigator.
Duration of response (DOR)
DOR in two arms based on RECIST V1.1 by IRRC and investigator.
Time to progression (TTP)
TTP in two arms based on RECIST V1.1 by IRRC and investigator.
Time to response (TTR)
TTR in two arms based on RECIST V1.1 by IRRC and investigator.
PFS
PFS in two arms based on mRECIST by IRRC.
Objective response rate (ORR)
Objective response rate (ORR) in two arms based on mRECIST by IRRC.
Time to progression (TTP)
TTP in two arms based on mRECIST by IRRC.
Duration of response (DOR)
DOR in two arms based on mRECIST by IRRC.
Disease control rate (DCR)
DCR in two arms based on mRECIST by IRRC.
Time to response (TTR)
TTR in two arms based on mRECIST by IRRC.
Anti-drug antibody (ADA)
Immunogenicity measured by anti-drug antibody (ADA) for Sintilimab and IBI305.
EORTC QLQ-C30
EORTC QLQ-HCC18

Full Information

First Posted
January 3, 2019
Last Updated
January 21, 2021
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03794440
Brief Title
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.
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）
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
595 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sintilimab +IBI305
Arm Type
Experimental
Arm Title
Sorafenib
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Other Intervention Name(s)
IBI308
Intervention Description
200mg IV d1， Q3W
Intervention Type
Drug
Intervention Name(s)
IBI305
Other Intervention Name(s)
anti-VEGF monoclonal antibody
Intervention Description
15mg/kg IV d1， Q3W
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
400mg PO BID
Primary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
up to 24 months after randomization
Title
Progression-free survival (PFS)
Description
Progression-free survival (PFS) in two arms based on RECIST V1.1 by Independent Radiological Review Committee, IRRC.
Time Frame
up to 24 months after randomization
Secondary Outcome Measure Information:
Title
PFS
Description
PFS in two arms based on RECIST V1.1 by investigator.
Time Frame
up to 24 months after randomization
Title
Objective response rate (ORR)
Description
Objective response rate (ORR) in two arms based on RECIST V1.1 by IRRC and investigator .
Time Frame
up to 24 months after randomization
Title
Disease control rate (DCR)
Description
DCR in two arms based on RECIST V1.1 by IRRC and investigator.
Time Frame
up to 24 months after randomization
Title
Duration of response (DOR)
Description
DOR in two arms based on RECIST V1.1 by IRRC and investigator.
Time Frame
up to 24 months after randomization
Title
Time to progression (TTP)
Description
TTP in two arms based on RECIST V1.1 by IRRC and investigator.
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.
Title
Time to response (TTR)
Description
TTR in two arms based on RECIST V1.1 by IRRC and investigator.
Time Frame
up to 24 months after randomization
Title
PFS
Description
PFS in two arms based on mRECIST by IRRC.
Time Frame
up to 24 months after randomization
Title
Objective response rate (ORR)
Description
Objective response rate (ORR) in two arms based on mRECIST by IRRC.
Time Frame
up to 24 months after randomization
Title
Time to progression (TTP)
Description
TTP in two arms based on mRECIST by IRRC.
Time Frame
up to 24 months after randomization
Title
Duration of response (DOR)
Description
DOR in two arms based on mRECIST by IRRC.
Time Frame
up to 24 months after randomization
Title
Disease control rate (DCR)
Description
DCR in two arms based on mRECIST by IRRC.
Time Frame
up to 24 months after randomization
Title
Time to response (TTR)
Description
TTR in two arms based on mRECIST by IRRC.
Time Frame
up to 24 months after randomization
Title
Anti-drug antibody (ADA)
Description
Immunogenicity measured by anti-drug antibody (ADA) for Sintilimab and IBI305.
Time Frame
up to 24 months after randomization
Title
EORTC QLQ-C30
Time Frame
up to 24 months after randomization
Title
EORTC QLQ-HCC18
Time Frame
up to 24 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). ECOG performance status between 0 and 1 No systematic anti-tumor treatment has been performed.(End of postoperative adjuvant chemotherapy for more than 6 months allowed). Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment. At least 1 lesion with measurable disease at baseline by RECIST V1.1. Child-Pugh: <=7 Adequate organ and bone marrow function. Exclusion Criteria: With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues. Have a history of hepatic encephalopathy or have a history of liver transplantation. With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion. Central nervous system (CNS) metastasis. Uncontrolled high blood pressure, systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg after optimal medical treatment. Local treatment for liver lesions within 4 weeks.
Facility Information:
Facility Name
Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34143971
Citation
Ren Z, Xu J, Bai Y, Xu A, Cang S, Du C, Li Q, Lu Y, Chen Y, Guo Y, Chen Z, Liu B, Jia W, Wu J, Wang J, Shao G, Zhang B, Shan Y, Meng Z, Wu J, Gu S, Yang W, Liu C, Shi X, Gao Z, Yin T, Cui J, Huang M, Xing B, Mao Y, Teng G, Qin Y, Wang J, Xia F, Yin G, Yang Y, Chen M, Wang Y, Zhou H, Fan J; ORIENT-32 study group. Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2-3 study. Lancet Oncol. 2021 Jul;22(7):977-990. doi: 10.1016/S1470-2045(21)00252-7. Epub 2021 Jun 15. Erratum In: Lancet Oncol. 2021 Aug;22(8):e347.
Results Reference
derived

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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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