Clinical trial NCT05263219: DEB-TACE+HAIC vs. HAIC for Large HCC
Official title: Transarterial Chemoembolization With Drug-eluting Beads Plus Hepatic Arterial Infusion Chemotherapy Versus Hepatic Arterial Infusion Chemotherapy Alone for Large Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Unresectable Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Transarterial chemoembolization
Hepatic arterial infusion chemotherapy
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Hainan General Hospital
name: Maoming People's Hospital
name: Zhongshan People's Hospital, Guangdong, China
name: Affiliated Hospital of Guangdong Medical University
name: First People's Hospital of Foshan
name: Jiangmen Central Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
First posted: 2022-03-02
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 alone for unresectable large hepatocellular carcinoma (HCC).

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 patients with initially unresectable large HCC (\> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE plus HAIC (dTACE-HAIC) or HAIC as the primary treatment using an 1:1 randomization scheme. In the dTACE-HAIC arm, the microcatheter will be reserved at the proper/left/right hepatic artery and chemotherapy drugs (FOLFOX-based regimen) will be intra-arterially administered though the microcatheter. The treatment can be repeated on demand (at a 4-6-week interval usually) based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In the HAIC arm, treatment will repeated once every 3 weeks for up to six cycles. During follow-up, the potential resectability of the tumor will be assessed by the multidisciplinary team (MDT). Once the tumors become resectable, curative surgical resection will be recommended for the patients.

The primary end point of this study is overall survival (OS). The secondary endpoints are tumor response (objective response rate and disease control rate), success rate of conversion to resection, progression-free survival (PFS), and adverse events (AEs).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 4 years.
Secondary outcomes:
measure: Objective response rate (ORR) per mRECIST.
timeFrame: 4 years.
measure: ORR per RECIST 1.1.
timeFrame: 4 years.
measure: Disease control rate (DCR) per mRECIST.
timeFrame: 4 years.
measure: DCR per RECIST 1.1.
timeFrame: 4 years.
measure: Progression free survival (PFS) per mRECIST.
timeFrame: 4 years.
measure: Progression free survival (PFS) per RECIST 1.1.
timeFrame: 4 years.
measure: Success rate of conversion to resection
timeFrame: 4 years.
measure: Adverse Events (AEs)
timeFrame: 4 years.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Second Affiliated Hospital of Guangzhou Medical University
name: Kangshun Zhu, Dr.
role: STUDY_CHAIR
References: