DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC

Phase 2

Recruiting

• Conditions: Hepatocellular Carcinoma Non-resectable
• Interventions: Drug: DEB-TACE+HAIC; Drug: DEB-TACE

• Registration Number: NCT06397235
• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

Brief Summary

This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) combined with hepatic artery infusion chemotherapy (HAIC) with oxaliplatin and raltitrexed (RALOX-HAIC) versus DEB-TACE alone for unresectable large hepatocellular carcinoma (HCC).

Detailed Description

This is a multicenter randomized study to evaluate the efficacy and safety of DEB-TACE plus RALOX-HAIC (DEB-TACE+HAIC) compared with DEB-TACE alone for unresectable large HCC (\>7cm).

130 patients with unresectable large HCC (\> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE+HAIC or DEB-TACE using an 1:1 randomization scheme. In the DEB-TACE+HAIC arm, the microcatheter will be reserved at the main hepatic tumor-feeding artery and chemotherapy drugs (RALOX-based regimen) will be intra-arterially administered though the microcatheter. In the DEB-TACE arm, patients will be treated with DEB-TACE alone. The treatments can be repeated on demand (at a 4-week interval usually) based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. 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 progression-free survival (PFS). The secondary endpoints are tumor response (objective response rate and disease control rate), overall survival (OS) , and adverse events (AEs).

Study Timeline

• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-04-29
• Study Start: 2024-05-01
• Study First Posted: 2024-05-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2027-04-30
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• HCC confirmed by histology/cytology or diagnosed clinically.
• At least one measurable intrahepatic target lesion.
• The largest tumor size > 7 cm.
• Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment.
• Child-Pugh score 5-7.
• ECOG performance status ≤ 1.
• Adequate organ and hematologic function with platelet count ≥75×10^9/L, leukocyte >3.0×10^9/L, Neutrophil count ≥1.5×10^9/L, ASL and AST≤5×ULN, creatinine clearance≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds.

Exclusion Criteria

• Macrovascular invasion or extrahepatic metastasis.
• Diffuse HCC.
• Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
• Previous palliative treatments, including TACE, transcatheter arterial embolization, HAIC, radiation therapy, systemic therapy.
• Organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment.
• History of other malignancies.
• Uncontrollable infection.
• History of HIV.
• Gastrointestinal bleeding within 30 days, or other bleeding> CTCAE grade 3.
• History of organ or cells transplantation.
• Pregnant or lactating patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEB-TACE+HAIC	DEB-TACE+HAIC	For DEB-TACE, superselective catheterization is performed and CalliSpheres loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In patients with huge or bilobar multiple lesions, in order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. After each chemoembolization, the microcatheter is reserved at the main hepatic tumor-feeding artery. The RALOX-based regimen is intra-arterially administered. During follow-up, the treatment will be repeated on demand (about 4-week interval) based on the evaluation of the follow-up laboratory and imaging examination.
DEB-TACE	DEB-TACE	Superselective catheterization is performed and CalliSpheres loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In patients with huge or bilobar multiple lesions, in order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session.

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	3 years	The time from date of randomization until the first occurrence of disease progression (according to mRECIST) or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	3 years	The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST.
Overall survival (OS)	4 years	The time from date of randomization to death due to any cause.
Adverse Events (AEs)	3 years	Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.
Disease control rate (DCR)	3 years	The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China