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

NCT04635527 | Terminated Phase 1

• 1 other identifier: CIBI318F101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  Up to 90 days post last dose

Secondary Outcomes (6)

• The percentage of subjects with pathological Complete Response (pCR) after liver resection

  3 years

• The percentage of subjects with major pathological response (MPR) after liver resection

  3 years

• The percentage of subjects with R0 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

Study Arms (2)

IBI318 combined with conventional TACE (cTACE)

EXPERIMENTAL

Drug: IBI318; Procedure: cTACE

Placebo combined with conventional TACE (cTACE)

PLACEBO COMPARATOR

Procedure: cTACE; Drug: placebo

Interventions

IBI318 DRUG

before surgery IBI318 intravenous injection Q2W,after surgery IBI318 intravenous injection Q4W

IBI318 combined with conventional TACE (cTACE)

cTACE PROCEDURE

conventional transarterial chemoembolization

IBI318 combined with conventional TACE (cTACE); Placebo combined with conventional TACE (cTACE)

placebo DRUG

before surgery placebo intravenous injection Q2W,after surgery placebo intravenous injection Q4W

Placebo combined with conventional TACE (cTACE)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

The First Affiliated Hospital Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: December 24, 2020
• Primary Completion: August 27, 2021
• Study Completion: March 7, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

CN (1)