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A Study on the Safety and Effectiveness of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI318
cTACE
placebo
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. Aged ≥ 18 years and ≤ 75 years at the time of consent.
  2. Hepatocellular carcinoma confirmed by histology/cytology.
  3. Lesions with measurable disease at baseline by mRECIST.
  4. Barcelona Clinic Liver Cancer stage A or B for hepatocellular carcinoma exceeding Milan criteria.
  5. Child-Pugh: <=6
  6. Adequate organ and bone marrow function.

Exclusion Criteria:

  1. With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
  2. Having previously received standard systemic therapy, ablative therapy, interventional therapy and surgical treatment for hepatocellular carcinoma.
  3. Potential liver transplant candidates
  4. Have a history of hepatic encephalopathy or have a history of liver transplantation.
  5. With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.

Sites / Locations

  • The First Affiliated Hospital Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IBI318 combined with conventional TACE (cTACE)

Placebo combined with conventional TACE (cTACE)

Arm Description

Outcomes

Primary Outcome Measures

Number of participants experiencing clinical and laboratory adverse events (AEs)

Secondary Outcome Measures

The percentage of subjects with pathological Complete Response (pCR) after liver resection
The percentage of subjects with major pathological response (MPR) after liver resection
The percentage of subjects with R0 resection
Objective response rate (ORR) in two arms based on mRECIST by investigator
Disease-free survival (DFS) in two arms based on mRECIST by investigator
Overall survival (OS) in two arms

Full Information

First Posted
November 13, 2020
Last Updated
March 14, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04635527
Brief Title
A Study on the Safety and Effectiveness of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma
Official Title
A Phase Ib Study to Evaluate the Safety and Efficacy of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to the company's development strategy adjustment ，Innovent Bioligics decided not to continue the study after consultation with investigators.
Study Start Date
December 24, 2020 (Actual)
Primary Completion Date
August 27, 2021 (Actual)
Study Completion Date
March 7, 2023 (Actual)

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 this phase Ib study is to assess the safety, tolerability and effectiveness of IBI318 in combination with conventional TACE (cTACE) in patients with potentially resected hepatocellular carcinoma.

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 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IBI318 combined with conventional TACE (cTACE)
Arm Type
Experimental
Arm Title
Placebo combined with conventional TACE (cTACE)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
IBI318
Intervention Description
before surgery IBI318 intravenous injection Q2W,after surgery IBI318 intravenous injection Q4W
Intervention Type
Procedure
Intervention Name(s)
cTACE
Intervention Description
conventional transarterial chemoembolization
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
before surgery placebo intravenous injection Q2W,after surgery placebo intravenous injection Q4W
Primary Outcome Measure Information:
Title
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time Frame
Up to 90 days post last dose
Secondary Outcome Measure Information:
Title
The percentage of subjects with pathological Complete Response (pCR) after liver resection
Time Frame
3 years
Title
The percentage of subjects with major pathological response (MPR) after liver resection
Time Frame
3 years
Title
The percentage of subjects with R0 resection
Time Frame
3 years
Title
Objective response rate (ORR) in two arms based on mRECIST by investigator
Time Frame
3 years
Title
Disease-free survival (DFS) in two arms based on mRECIST by investigator
Time Frame
3 years
Title
Overall survival (OS) in two arms
Time Frame
3 years

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: Aged ≥ 18 years and ≤ 75 years at the time of consent. Hepatocellular carcinoma confirmed by histology/cytology. Lesions with measurable disease at baseline by mRECIST. Barcelona Clinic Liver Cancer stage A or B for hepatocellular carcinoma exceeding Milan criteria. Child-Pugh: <=6 Adequate organ and bone marrow function. Exclusion Criteria: With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues. Having previously received standard systemic therapy, ablative therapy, interventional therapy and surgical treatment for hepatocellular carcinoma. Potential liver transplant candidates 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.
Facility Information:
Facility Name
The First Affiliated Hospital Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Learn more about this trial

A Study on the Safety and Effectiveness of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma

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