HAIC Combined With Lenvatinib and Sintilimab for Hepatocellular Carcinoma With PVTT

  • STATUS
    Recruiting
  • days left to enroll
    31
  • participants needed
    30
  • sponsor
    Sun Yat-sen University
Updated on 26 January 2021

Summary

This study intends to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and Sintilimab for patients hepatocellular carcinoma and portal vein tumor thrombus.

Description

Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and Sintilimab, an programmed cell death protein-1 (PD-1) antibody, was effective and tolerable in patients with hepatocellular carcinoma and portal vein tumor thrombus. No study has evaluated HAIC plus Lenvatinib and Sintilimab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Details
Condition LIVER DISEASE, LIVER DISEASE, Liver Disorders, HEPATIC NEOPLASM, Liver Cancer, Neoplasm of unspecified nature of digestive system, Digestive System Neoplasms, HEPATOCELLULAR CARCINOMA, Portal Vein Tumor Thrombus, Liver Cancer, Liver Disorders, Digestive System Neoplasms, Sintilimab, hepatoma, tumor liver, liver tumor, liver tumours, liver cell carcinoma
Treatment Lenvatinib, Hepatic arterial infusion chemotherapy, Sintilimab
Clinical Study IdentifierNCT04618367
SponsorSun Yat-sen University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\. clinical diagnosis of HCC; 2. age between18 and 75 years; 3. refused to sorafenib treatment; 4. type I PVTT, type II PVTT, or type III PVTT. 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

\. Diffuse HCC; 2. Extrahepatic metastasis; 3. Obstructive PVTT involving both the left and right portal vein or 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
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