bTAE-HAIC Combined With System Therapy for Intermediate-advanced Huge HCC
Study Details
Study Description
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 intermediate-advanced huge hepatocellular carcinoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: bTAE-HAIC combined with Lenvatinib and Camrelizumab 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. |
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.
Other Names:
Drug: Camrelizumab
200mg intravenously every 2 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Objective response rate (ORR) [6 months]
ORR, as determined based on tumor response according to RECIST 1.1, is defined as
Secondary Outcome Measures
- Progression free survival (PFS) [6 months]
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.
Other Outcome Measures
- Overall survival (OS) [12 months]
OS is the length of time from the date of inclusion until death from any cause.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Clinical diagnosis of HCC.
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Age between 18 and 75 years;
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The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;
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Intermediate-advanced huge HCC, advanced HCC with PVTT type I or type II or limited metastases (≤5).
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Child-Pugh class A or B;
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Eastern Cooperative Group performance status (ECOG) score of 0-2;
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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
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Prothrombin time ≤18s or international normalized ratio < 1.7.
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Ability to understand the protocol and to agree to and sign a written informed consent document.
Exclusion Criteria:
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Diffuse HCC;
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Extrahepatic metastasis >5;
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Obstructive PVTT involving the main portal vein.
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Serious medical comorbidities.
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Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
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Known history of HIV
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History of organ allograft
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Known or suspected allergy to the investigational agents or any agent given in association with this trial.
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Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
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Evidence of bleeding diathesis.
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Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen University Cancer Center | Guanzhou | Guangdong | China | 510000 |
Sponsors and Collaborators
- Zhou Qunfang
Investigators
- Study Director: Zhimei Hunag, MD, Sun Yat-sen University
- Study Director: Jinhua Huang, Profession, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Liver Project 3