Status:
RECRUITING
DEB-TACE+HAIC vs. HAIC for Large HCC
Lead Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Collaborating Sponsors:
Hainan General Hospital
Maoming People's Hospital
Conditions:
Unresectable Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) plus hepatic artery infusion chemotherapy (HAIC) compared with HAIC al...
Detailed Description
This is a multicenter, prospective and randomized study to evaluate the efficacy and safety of DEB-TACE (with CalliSpheres) plus HAIC compared with HAIC alone for unresectable large HCC (\>7cm). 230 ...
Eligibility Criteria
Inclusion
- Patients with HCC confirmed by histology/cytology or diagnosed clinically.
- The maximum HCC lesion \> 7 cm.
- Unresectable HCC evaluated by the surgeon team.
- At least one measurable intrahepatic target lesion.
- Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A.
- ECOG score of performance status ≤ 1 point.
- Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR\<1.5 or PT/APTT normal range.
- Life expectancy of at least 3 months.
Exclusion
- Accompanied with tumor thrombus involving the main portal vein or bilateral first-order branch of portal vein.
- Accompanied with vena cava tumor thrombus.
- Extrahepatic metastasis.
- Previous treatment with TACE, HAIC, liver transplantation, resection, ablation, radiotherapy, or systemic therapy.
- Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
- Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE or HAIC treatment.
- History of other malignancies.
- Uncontrollable infection.
- History of HIV.
- Allergic to the drugs involved in the research.
- Patients with gastrointestinal bleeding within 30 days, or other bleeding\> CTCAE grade 3.
- History of organ or cells transplantation.
- Those with bleeding tendency.
Key Trial Info
Start Date :
February 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 9 2026
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT05263219
Start Date
February 10 2022
End Date
February 9 2026
Last Update
June 22 2023
Active Locations (1)
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1
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260