HAIC Plus Sorafenib Versus TACE Plus Sorafenibfor Advanced HCC
NCT ID: NCT02856126
Last Updated: 2024-07-23
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.
COMPLETED
PHASE3
214 participants
INTERVENTIONAL
2016-08-31
2024-07-31
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 Versus TACE for Large Hepatocellular Carcinoma Staged BCLC A/B.
NCT02973685
TACE-HAIC vs. HAIC for Potentially Resectable HCC
NCT03591705
The Efficacy and Safety of HAIC With FOLFOX vs Sorafenib for Patients Who Showed TACE-resistant: a Retrospective Study
NCT05121571
HAIC Plus PD-1 Antibody vs HAIC Plus Sorafenib for Advanced HCC
NCT03780634
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
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HAIC plus sorafenib
Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: HAIC Regimen Drug: Oral Sorafenib
Hepatic arterial infusion chemotherapy
HAIC Regimen
Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
Oral Sorafenib
Oral Sorafenib, 400mg, Bid
TACE plus sorafenib
Procedure/Surgery: Transarterial chemoembolization Drug: TACE regimen Drug: Oral Sorafenib
Transarterial chemoembolization
TACE regimen
infusion with lipiodol mixed with chemotherapy drugs (EADM , lobaplatin, and MMC ), and embolization with polyvinyl alcohol particles (PVA)
Oral Sorafenib
Oral Sorafenib, 400mg, Bid
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hepatic arterial infusion chemotherapy
Transarterial chemoembolization
TACE regimen
infusion with lipiodol mixed with chemotherapy drugs (EADM , lobaplatin, and MMC ), and embolization with polyvinyl alcohol particles (PVA)
HAIC Regimen
Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
Oral Sorafenib
Oral Sorafenib, 400mg, Bid
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 EASL criteria.
* with no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:
* Platelet count ≥ 75,000/µL
* Hemoglobin ≥ 8.5 g/dL
* Total bilirubin ≤ 30mmol/L
* Serum albumin ≥ 30 g/L
* ASL and AST ≤ 5 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
* Ability to understand the protocol and to agree to and sign a written informed consent document
Exclusion Criteria
* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug
* Serious non-healing wound, ulcer, or bone fracture
* Known central nervous system tumors including metastatic brain disease
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
The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dongguan People's Hospital
Dongguan, Guangdong, China
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Guangzhou Twelfth People 's Hospital
Guangzhou, Guangdong, China
Kaiping Central Hospital
Kaiping, Guangdong, China
The First Affiliated Hospital of University Of South China
Hengyang, Hunan, China
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi’an, Shanxi, 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.
HCC-S022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.