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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06061276
Other study ID # Liver Project 3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 20, 2024
Est. completion date December 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
Health authority
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 intermediate-advanced huge 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. Camrelizumab, a programmed cell death protein-1 (PD-1) inhibitor, is effective and tolerable in patients with unresectable hepatocellular carcinoma. No study has evaluated bTAE-HAIC plus Lenvatinib and Camrelizumab. Thus, the investigators carried out this prospective, single-arm study to find out it.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Clinical diagnosis of HCC. 2. Age between 18 and 75 years; 3. The maximum tumor size =10 cm, and the total tumor size =15 cm; 4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I or type II or limited metastases (=5). 5. Child-Pugh class A or B; 6. Eastern Cooperative Group performance status (ECOG) score of 0-2; 7. 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 8. Prothrombin time =18s or international normalized ratio < 1.7. 9. Ability to understand the protocol and to agree to and sign a written informed consent document. Exclusion Criteria: 1. Diffuse HCC; 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.

Study Design


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.
Camrelizumab
200mg intravenously every 2 weeks

Locations

Country Name City State
China Sun Yat-sen University Cancer Center Guanzhou 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
Other Overall survival (OS) OS is the length of time from the date of inclusion until death from any cause. 12 months
Primary Objective response rate (ORR) ORR, as determined based on tumor response according to RECIST 1.1, is defined as 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
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