dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Intermediate and Advanced Hepatocellular Carcinoma: a Prospective Phase II Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Chinese PLA General hospital
RECRUITING
Beijing
Contact Information
Primary
Qunfang Zhou, MD
zhouqun988509@163.com
86 19868000115
Backup
Ye Liang, MD
2575179115@qq.com
8618824105018
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 27
Treatments
Experimental: dTACE-HAIC plus Bevacizumab and Atezolizumab
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.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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