Clinical trial NCT06397235: DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC
Official title: DEB-TACE in Combination With or Without RALOX-based HAIC for Unresectable Large Hepatocellular Carcinoma: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma Non-resectable
Keywords: Hepatocellular Carcinoma
transarterial chemoembolization
drug-eluting beads
hepatic artery infusion chemotherapy
oxaliplatin
raltitrexe
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Zhongshan People's Hospital, Guangdong, China
name: Guangzhou Development District Hospital
name: The Affiliated Shunde Hospital of Jinan University
First posted: 2024-05-02
Enrollment: 130
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) 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).

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.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 3 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 3 years
measure: Disease control rate (DCR)
timeFrame: 3 years
measure: Overall survival (OS)
timeFrame: 4 years
measure: Adverse Events (AEs)
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: