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A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
IBI310
Sintilimab
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 - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically/cytologically confirmed hepatocellular carcinoma, or liver cirrhosis meeting the clinical diagnostic criteria;
  2. ECOG performance status score of 0 or 1 point;
  3. No systemic antitumor treatment for hepatocellular carcinoma before the first administration;
  4. Barcelona Clinic Liver Cancer stage C, or Stage B not suitable for radical surgery and/or local treatment;
  5. At least 1 measurable lesion according to RECIST V1.1);
  6. Child-Pugh:≤6
  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

  • Fudan Universtiy Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sintilimab combined with IBI310

Sorafenib

Arm Description

Outcomes

Primary Outcome Measures

Overall survival (OS)
Objective response rate (ORR)
Objective response rate (ORR) in two arms based on RECIST V1.1 by the IRRC

Secondary Outcome Measures

Progression-free survival (PFS)
Progression-free survival (PFS) in two arms based on RECIST V1.1 by the IRRC and investigator
Duration of response(DOR)
Duration of response(DOR) in two arms based on RECIST V1.1 by the IRRC and investigator
Disease control rate(DCR)
Disease control rate(DCR) in two arms based on RECIST V1.1 by the IRRC and investigator
Time to progression(TTP)
Time to progression(TTP) in two arms based on RECIST V1.1 by the IRRC and investigator
Time to response(TTR)
Time to response(TTR) in two arms based on RECIST V1.1 by the IRRC and investigator
The incidence and severity of Treatment-Emergent Adverse Events

Full Information

First Posted
January 13, 2021
Last Updated
September 16, 2022
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04720716
Brief Title
A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC
Official Title
A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (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
Yes

5. Study Description

Brief Summary
This is a randomized, open-label, controlled, multicenter Phase III study to evaluate the effectiveness and safety of IBI310 combined with sintilimab and sorafenib in patients with locally advanced or metastatic HCC who have not previously received systemic therapy, are unsuitable for radical surgical resection or local treatment, or have had progressive disease after surgical resection or local treatment.

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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
490 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sintilimab combined with IBI310
Arm Type
Experimental
Arm Title
Sorafenib
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
IBI310
Intervention Description
IBI310 IV d1, Q6W
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Intervention Description
sintilimab IV d1, Q3W
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Sorafenib 400mg po
Primary Outcome Measure Information:
Title
Overall survival (OS)
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 the IRRC
Time Frame
up to 24 months after randomization
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
Progression-free survival (PFS) in two arms based on RECIST V1.1 by the IRRC and investigator
Time Frame
up to 24 months after randomization
Title
Duration of response(DOR)
Description
Duration of response(DOR) in two arms based on RECIST V1.1 by the IRRC and investigator
Time Frame
up to 24 months after randomization
Title
Disease control rate(DCR)
Description
Disease control rate(DCR) in two arms based on RECIST V1.1 by the IRRC and investigator
Time Frame
up to 24 months after randomization
Title
Time to progression(TTP)
Description
Time to progression(TTP) in two arms based on RECIST V1.1 by the IRRC and investigator
Time Frame
up to 24 months after randomization
Title
Time to response(TTR)
Description
Time to response(TTR) in two arms based on RECIST V1.1 by the IRRC and investigator
Time Frame
up to 24 months after randomization
Title
The incidence and severity of Treatment-Emergent Adverse Events
Time Frame
up to 24 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically/cytologically confirmed hepatocellular carcinoma, or liver cirrhosis meeting the clinical diagnostic criteria; ECOG performance status score of 0 or 1 point; No systemic antitumor treatment for hepatocellular carcinoma before the first administration; Barcelona Clinic Liver Cancer stage C, or Stage B not suitable for radical surgery and/or local treatment; At least 1 measurable lesion according to RECIST V1.1); Child-Pugh:≤6 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronghua Zhang
Phone
15267110561
Email
ronghua.zhang@innoventbio.com
Facility Information:
Facility Name
Fudan Universtiy Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Fan
Phone
021-64041990
Email
Fan.jia@zs-hospital.sh.cn

12. IPD Sharing Statement

Learn more about this trial

A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC

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