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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: IBI318
* Procedure: cTACE
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Overall survival (OS) in two arms |  | 3 years |