bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma

NCT06070636 | Recruiting DMC

• 1 other identifier: Liver Project 4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to evaluate the efficacy and safety of blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab for patients with infiltrative hepatocellular carcinoma.

Conditions

Liver Diseases; Hepatocellular Carcinoma; Immunotherapy; Lenvatinib; Sintilimab

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR, as determined based on tumor response according to RECIST 1.1

  6 months

Secondary Outcomes (2)

• Progression free survival (PFS)

  6 months

• Overall survival (OS)

  12 months

Study Arms (1)

bTAE-HAIC combined with Lenvatinib and Sintilimab

EXPERIMENTAL

bTAE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then blank microspheres were used according to the tumor blood supply vessels (40-120um, 100-300um, 300-500um, 500-700um). Hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 4 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Sintilimab, 200 mg intravenously every 3 weeks.

Procedure: bTAE-HAIC; Drug: Lenvatinib; Drug: Sintilimab

Interventions

bTAE-HAIC PROCEDURE

bTAE procedure was a 2.8-F microcatheter was superselectively inserted into the tumor feeding artery using the coaxial technique. Then blank microspheres were used according to the tumor blood supply vessels (40-120um, 100-300um, 300-500um, 500-700um). 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.

bTAE-HAIC combined with Lenvatinib and Sintilimab

Lenvatinib DRUG

12 mg (or 8 mg) once daily (QD) oral dosing.

Also known as: TKI inhibits

bTAE-HAIC combined with Lenvatinib and Sintilimab

Sintilimab DRUG

200mg intravenously every 32 weeks

Also known as: programmed cell death protein-1 (PD-1) antibody

bTAE-HAIC combined with Lenvatinib and Sintilimab

Eligibility Criteria

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

You may qualify if:

• Diagnosis of infiltrative HCC.
• Infiltrative HCC was characterized as follows: nonencapsulated arterial phase hyperenhancement; tumor washout in the period of portal phase, and noncircular, ill-defined margin
• Age between 18 and 75 years;
• The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;
• Infiltrative HCC, with PVTT type I or type II or limited metastases (≤5).
• Child-Pugh class A or B;
• Eastern Cooperative Group performance status (ECOG) score of 0-2;
• 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:

• HCC with capsule;
• Extrahepatic metastasis \>5;
• Obstructive PVTT involving the main portal vein.
• Serious medical comorbidities.
• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
• Known history of HIV
• History of organ allograft
• 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)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Liver Diseases; Carcinoma, Hepatocellular

Interventions

lenvatinib; sintilimab; Antibodies

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Zhimei Hunag, MD

  Sun Yat-sen University

  STUDY DIRECTOR

• Jinhua Huang, Professor

  Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Qunfnag Zhou, MD

CONTACT

86 19868000115; zhouqun988509@163.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 30, 2023
• First Posted: October 6, 2023
• Study Start: May 20, 2024
• Primary Completion: January 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)