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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04635527
• Other study ID #: CIBI318F101
• Status: Terminated
• Phase: Phase 1
• Start date: December 24, 2020
• Est. completion date: March 7, 2023

Study information

• Verified date: March 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 7, 2023
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• IBI318
before surgery IBI318 intravenous injection Q2W,after surgery IBI318 intravenous injection Q4W

Procedure:
• cTACE
conventional transarterial chemoembolization

Drug:
• placebo
before surgery placebo intravenous injection Q2W,after surgery placebo intravenous injection Q4W

Locations

Country	Name	City	State
China	The First Affiliated Hospital Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing clinical and laboratory adverse events (AEs)		Up to 90 days post last dose
Secondary	The percentage of subjects with pathological Complete Response (pCR) after liver resection		3 years
Secondary	The percentage of subjects with major pathological response (MPR) after liver resection		3 years
Secondary	The percentage of subjects with R0 resection		3 years
Secondary	Objective response rate (ORR) in two arms based on mRECIST by investigator		3 years
Secondary	Disease-free survival (DFS) in two arms based on mRECIST by investigator		3 years
Secondary	Overall survival (OS) in two arms		3 years