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

Innovent Biologics

Status and phase: Terminated; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: cTACE; Drug: placebo; Drug: IBI318

Study type: Interventional

Funder types: Industry

Identifiers

NCT04635527

CIBI318F101

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

IBI318 combined with conventional TACE (cTACE)

Experimental group

Treatment:

Drug: IBI318

Procedure: cTACE

Placebo combined with conventional TACE (cTACE)

Placebo Comparator group

Treatment:

Drug: placebo

Procedure: cTACE