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

Hepatocellular Carcinoma Non-resectable Clinical Trial

Official title:

DEB-TACE in Combination With or Without RALOX-based HAIC for Unresectable Large Hepatocellular Carcinoma: A Single-center, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06397235
• Other study ID #: MIIR-19
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: April 30, 2028

Study information

• Verified date: May 2024
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

This is a single-center, 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: April 30, 2028
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Non-resectable

Intervention

Drug:
• DEB-TACE+HAIC
CalliSpheres (100-300 µm) loaded with pirarubicin for transarterial chemombolization: Typically, one vial of the beads was loaded with 60 mg pirarubicin. If blushed tumors is still visible after the embolization with one vial of beads, regular microspheres (8spheres) with diameters of 100-700 µm are additionally injected. RALOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 85 mg/m2 infusion for 2 hours; Raltitrexed, 3 mg/m2 infusion for 0.5 hour.
• DEB-TACE
CalliSpheres (100-300 µm) loaded with pirarubicin for transarterial chemombolization: Typically, one vial of the beads was loaded with 60 mg pirarubicin. If blushed tumors is still visible after the embolization with one vial of beads, regular microspheres (8spheres) with diameters of 100-700 µm are additionally injected.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

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