A Study on the Safety and Effectiveness of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma
NCT ID: NCT04635527
Last Updated: 2023-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
10 participants
INTERVENTIONAL
2020-12-24
2023-03-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation
NCT02631499
A Study of TAC-101 in Combination With TACE Versus TACE Alone in Asian Patients With Advanced Hepatocellular Carcinoma
NCT00756782
TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Intermediate-stage HCC
NCT05250843
Trans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma
NCT02418988
Combined Locoregional Treatment With Immunotherapy for Unresectable HCC.
NCT04220944
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IBI318 combined with conventional TACE (cTACE)
IBI318
before surgery IBI318 intravenous injection Q2W,after surgery IBI318 intravenous injection Q4W
cTACE
conventional transarterial chemoembolization
Placebo combined with conventional TACE (cTACE)
cTACE
conventional transarterial chemoembolization
placebo
before surgery placebo intravenous injection Q2W,after surgery placebo intravenous injection Q4W
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IBI318
before surgery IBI318 intravenous injection Q2W,after surgery IBI318 intravenous injection Q4W
cTACE
conventional transarterial chemoembolization
placebo
before surgery placebo intravenous injection Q2W,after surgery placebo intravenous injection Q4W
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital Zhejiang University
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CIBI318F101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.