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

March 14, 2023 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBI318 combined with conventional TACE (cTACE)
Drug: IBI318
before surgery IBI318 intravenous injection Q2W,after surgery IBI318 intravenous injection Q4W
Procedure: cTACE
conventional transarterial chemoembolization
Placebo Comparator: Placebo combined with conventional TACE (cTACE)
Procedure: cTACE
conventional transarterial chemoembolization
Drug: placebo
before surgery placebo intravenous injection Q2W,after surgery placebo intravenous injection Q4W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time Frame: Up to 90 days post last dose
Up to 90 days post last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
The percentage of subjects with pathological Complete Response (pCR) after liver resection
Time Frame: 3 years
3 years
The percentage of subjects with major pathological response (MPR) after liver resection
Time Frame: 3 years
3 years
The percentage of subjects with R0 resection
Time Frame: 3 years
3 years
Objective response rate (ORR) in two arms based on mRECIST by investigator
Time Frame: 3 years
3 years
Disease-free survival (DFS) in two arms based on mRECIST by investigator
Time Frame: 3 years
3 years
Overall survival (OS) in two arms
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2020

Primary Completion (Actual)

August 27, 2021

Study Completion (Actual)

March 7, 2023

Study Registration Dates

First Submitted

November 13, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI318F101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on IBI318

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe