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

Trial Title: DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC

NCT ID: NCT06397235

Condition: Hepatocellular Carcinoma Non-resectable

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Chlorotrianisene

Conditions: Keywords:
Hepatocellular Carcinoma
transarterial chemoembolization
drug-eluting beads
hepatic artery infusion chemotherapy
oxaliplatin
raltitrexe

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: DEB-TACE+HAIC
Description: 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.
Arm group label: DEB-TACE+HAIC

Intervention type: Drug
Intervention name: DEB-TACE
Description: 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.
Arm group label: DEB-TACE

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 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).

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: The Second Affiliated Hospital of Guangzhou Medical University

Address:
City: Guangzhou
Zip: 510260
Country: China

Status: Recruiting

Contact:
Last name: Kangshun Zhu, Dr.

Phone: +86-20-34156205
Email: zhksh010@126.com

Investigator:
Last name: Kangshun Zhu, Dr.
Email: Principal Investigator

Investigator:
Last name: Mingyue Cai, Dr.
Email: Sub-Investigator

Start date: May 1, 2024

Completion date: April 30, 2028

Lead sponsor:
Agency: Second Affiliated Hospital of Guangzhou Medical University
Agency class: Other

Source: Second Affiliated Hospital of Guangzhou Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06397235