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

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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04635527
Enrollment
10
Registered
2020-11-19
Start date
2020-12-24
Completion date
2023-03-07
Last updated
2023-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

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.

Interventions

DRUGIBI318

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

PROCEDUREcTACE

conventional transarterial chemoembolization

DRUGplacebo

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

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Number of participants experiencing clinical and laboratory adverse events (AEs)Up to 90 days post last dose

Secondary

MeasureTime frame
The percentage of subjects with R0 resection3 years
The percentage of subjects with pathological Complete Response (pCR) after liver resection3 years
The percentage of subjects with major pathological response (MPR) after liver resection3 years
Disease-free survival (DFS) in two arms based on mRECIST by investigator3 years
Overall survival (OS) in two arms3 years
Objective response rate (ORR) in two arms based on mRECIST by investigator3 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026