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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06070636
• Other study ID #: Liver Project 4
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Sun Yat-sen University
• Contact: Qunfnag Zhou, MD
• Phone: 86 19868000115
• Email: zhouqun988509[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Blank-microsphere transcatheter arterial embolization (bTAE) and hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin are effective and safe for hepatocellular carcinoma. Lenvatinib is non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. Sintilimab, a programmed cell death protein-1 (PD-1) inhibitor, is effective and safe in patients with unresectable hepatocellular carcinoma. No study has evaluated bTAE-HAIC plus Lenvatinib and Sintilimab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of infiltrative HCC.

2. Infiltrative HCC was characterized as follows: nonencapsulated arterial phase hyperenhancement; tumor washout in the period of portal phase, and noncircular, ill-defined margin

3. Age between 18 and 75 years;

4. The maximum tumor size =10 cm, and the total tumor size =15 cm;

5. Infiltrative HCC, with PVTT type I or type II or limited metastases (=5).

6. Child-Pugh class A or B;

7. Eastern Cooperative Group performance status (ECOG) score of 0-2;

8. 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

9. Prothrombin time =18s or international normalized ratio < 1.7.

10. Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

1. HCC with capsule;

2. Extrahepatic metastasis >5;

3. Obstructive PVTT involving the main portal vein.

4. Serious medical comorbidities.

5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy

6. Known history of HIV

7. History of organ allograft

8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.

9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

10. Evidence of bleeding diathesis.

11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Immunotherapy
• Lenvatinib
• Liver Diseases
• Sintilimab

Intervention

Procedure:
• bTAE-HAIC
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.

Drug:
• Lenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing.
• Sintilimab
200mg intravenously every 32 weeks

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	ORR, as determined based on tumor response according to RECIST 1.1	6 months
Secondary	Progression free survival (PFS)	PFS is defined as the time from the date of inclusion to the date of the first objectively documented tumor progression or death due to any cause.	6 months
Secondary	Overall survival (OS)	OS is the length of time from the date of inclusion until death from any cause.	12 months