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

Phase 1

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: cTACE; Drug: IBI318; Drug: placebo

• Registration Number: NCT04635527
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-19
• Study Start: 2020-12-24
• Primary Completion: 2021-08-27
• Status Verified: 2023-03
• Study Completion: 2023-03-07
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo combined with conventional TACE (cTACE)	cTACE	-
Placebo combined with conventional TACE (cTACE)	placebo	-
IBI318 combined with conventional TACE (cTACE)	IBI318	-
IBI318 combined with conventional TACE (cTACE)	cTACE	-

Primary Outcome Measures

Name	Time	Method
Number of participants experiencing clinical and laboratory adverse events (AEs)	Up to 90 days post last dose

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China