HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B
NCT ID: NCT03780049
Last Updated: 2020-05-21
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.
UNKNOWN
PHASE3
304 participants
INTERVENTIONAL
2018-10-01
2023-10-01
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.
HAIC Versus TACE for Large and Unresectable Hepatocellular Carcinoma Staged BCLC A/B
NCT03048123
HAIC Plus A+T for Patients With High-risk HCC: a Single-arm Phase 2 Trial
NCT05886465
HAIC Plus Targeted Therapy and/or PD-1 Inhibitors for Unresectable Intrahepatic Cholangiocarcinoma
NCT05489692
HAIC Plus Sorafenib Versus TACE Plus Sorafenibfor Advanced HCC
NCT02856126
Neoadjuvant HAIC for Resectable Hepatocellular Carcinoma Beyond Milan Criteria
NCT03469479
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.
HAIC plus H101
Patients receive oxaliplatin, 5-fluorouracil and leucovorin and recombinant human type-5 adenovirus 0.5ml via hepatic artery
HAIC of FOLFOX
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
H101
Patients receive H101 0.5ml dissolved in 10ml normal saline in each session of HAIC
HAIC
Patients receive oxaliplatin, 5-fluorouracil and leucovorin and normal saline via hepatic artery
HAIC of FOLFOX
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Placebos
Patients receive normal saline 10ml in each session of HAIC
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HAIC of FOLFOX
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
H101
Patients receive H101 0.5ml dissolved in 10ml normal saline in each session of HAIC
Placebos
Patients receive normal saline 10ml in each session of HAIC
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
* With no previous treatment
* Single lesion with tumor size larger 7cm or multiple lesions
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* BCLC A-B stage
* The following laboratory parameters:
Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
Exclusion Criteria
* With other malignant tumors
* Known or suspected allergy to the investigational agents or any agent given in association with this trial
* History of organ allograft
* Pregnant or lactating woman
* patients with poor compliance
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Yat-sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Shi Ming
Proffessor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ming Shi, MD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HCC-S032
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.