dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma

NCT06609863 | Recruiting

• 1 other identifier: Liver Projiect 9
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to evaluate the efficacy and safety of drug-eluting transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (dTACE-HAIC) plus Bevacizumab and Atezolizumab for patients with intermediate-advanced huge hepatocellular carcinoma.

Conditions

Advanced Hepatocellular Carcinoma; Atezolizumab; Bevacizumab; Chemotherapy

Keywords

hepatocellular carcinoma; Atezolizumab; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.

  12 months

Secondary Outcomes (2)

• Progression-Free-Survival (PFS)

  12 months

• Overall survival (OS)

  24 months

Study Arms (1)

dTACE-HAIC plus Bevacizumab and Atezolizumab

EXPERIMENTAL

dTACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then drug-eluting microspheres was used (100-300um, 300-500um). Hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 4 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab, 200 mg intravenously every 2 weeks.

Procedure: dTACE-HAIC

Interventions

dTACE-HAIC PROCEDURE

dTACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then drug-eluting microspheres were used (100-300um). The microcatheter was reserved at the proper/left/right hepatic artery according tumor location. After the patient returned to the ward, the following FOLFOX-based regime was intra-arterially administered through the microcatheter. The FOLFOX regimen was administered via the hepatic artery as follows: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1, and 400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2. Hepatic arterial infusion chemotherapy administration of oxaliplatin, fluorouracil, and leucovorin via the tumor feeding arteries every 4 weeks

dTACE-HAIC plus Bevacizumab and Atezolizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of HCC.
• Age between 18 and 75 years;
• The maximum tumor size ≥10 cm;
• Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
• limited metastases (≤5).
• Child-Pugh class A or B;
• Eastern Cooperative Group performance status (ECOG) score of 0-1;
• Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
• Prothrombin time ≤18s or international normalized ratio \< 1.7.
• Ability to understand the protocol and to agree to and sign a written informed consent document.

You may not qualify if:

• Diffuse HCC;
• Extrahepatic metastasis \>5;
• Obstructive PVTT involving mesenteric vena cava (PVTT IV).
• Serious medical comorbidities.
• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
• untreated or incompletely treated esophageal or gastric varices (assessed with esophagogastroduodenoscopy) with bleeding or high risk of bleeding.
• Eastern Cooperative Group performance status (ECOG) score of ≥2;
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Evidence of bleeding diathesis.
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Chinese PLA General hospital

Beijing, None Selected, 100853, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Feng Duan, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qunfang Zhou, MD

CONTACT

86 19868000115; zhouqun988509@163.com

Ye Liang, MD

CONTACT

8618824105018; 2575179115@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 3, 2024

Record last verified: 2024-12

Locations

CN (1)