HAIC+Lenvatinib+Tislelizumab vs D-TACE+Lenvatinib+Tislelizumab for Unresectable HCC

HAIC Combined With Lenvatinib and Tislelizumab Versus D-TACE Combined With Lenvatinib and Tislelizumab in Advanced Unresectable Hepatocellular Carcinoma

Drug-eluting Bead-Transarterial chemoembolization (D-TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of D-TACE for patients in Advanced Unresectable HCC. The investigators previous study also revealed similar results in Advanced Unresectable HCC patients treated with D-TACE. Recently, the investigators previous study demonstrated that, compared with D-TACE, hepatic arterial infusion chemotherapy (HAIC) may improve tumor response in Advanced Unresectable HCC. Thus, the investigators carried out this prospective nonrandomized control to demonstrate the superiority of HAIC-based combination therapy over D-TACE-based combination therapy.

Study Overview

• Status: Recruiting
• Conditions: Unresectable Hepatocellular Carcinoma
• Intervention / Treatment: Drug: HAIC; Drug: Lenvatinib; Drug: tislelizumab; Drug: D-TACE

Detailed Description

HCC is one of the most common malignant tumors with the worst prognosis. At present, except for liver transplantation, surgical resection is the most effective therapy for patients with HCC. However, many patients are found to have advanced cancer as soon as they were diagnosed and lose the opportunity of radical resection and treatments are limited.More and more clinical research failures have hit the investigators' hard, until a clinical study named IMbrave150, published in the New England Journal of Medicine in 2020. It has opened up a new era of combination therapy, breaking the pattern of only a single mode of advanced liver cancer for more than ten years, making the investigators realize that for the treatment of patients with advanced liver cancer, the single treatment effect is often very limited, and combination therapy is the future.The investigators recent research showed that HAIC Combined With Lenvatinib and Tislelizumab brings good results to patients with advanced HCC.To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to compare the safety and efficacy between HAIC-based combination therapy and D-TACE-based combination therapy for those patients in Advanced Unresectable HCC.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wen Li, PHD; Phone Number: 18870050597; Email: lw1042@126.com
• Study Contact Backup: Name: Lu Fang, PHD; Phone Number: 13507911672; Email: fanglu@medmail.com.cn

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Recruiting
      • The Second Affiliated Hospital of Nanchang University
      • Contact: Wen Li, PHD; Phone Number: 18870050597; Email: lw1042@126.com
      • Contact: Lu Fang, PHD; Phone Number: 13507911672; Email: fanglu@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with advanced unresectable hepatocellular carcinoma treated by D- TACE, or HAIC combined with Lenvatinib and Tislelizumab as initial treatment
• Age between 18 and 75 years
• Child-Pugh A or B liver function
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Adequate hematologic blood counts (white blood cell count >3ⅹ109/L, absolute neutrophil count >1.5ⅹ109/L, platelet count >10ⅹ109/L, hemoglobin concentration >85 g/L
• No extrahepatic metastasis

Exclusion Criteria:

• Severe underlying cardiac, pulmonary, or renal diseases
• History of a second primary malignant tumor
• Incomplete medical data
• Loss to follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HAIC+lenvatinib+tislelizumab; Hepatic Arterial Infusion Chemotherapy Combined With lenvatinib and tislelizumab	Drug: HAIC; FOLFOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 100 mg/m2 infusion for 2 hours; calcium levofolinate, 200 mg/m2 infusion for 1 hours; and 5-FU, 400 mg/m2 bolus infusion and then 2400 mg/m2 continuous infusion over 46 h.; Other Names: HAIC+Lenvatinib+tislelizumab; Drug: Lenvatinib; 12 mg/d for bodyweight ⩾ 60 kg or 8 mg/d for bodyweight <60 kg; Other Names: Targeted therapy; Drug: tislelizumab; tislelizumab 200 mg, every 3 weeks.; Other Names: PD-1 inhibitors
Experimental: D-TACE+lenvatinib+tislelizumab; Transarterial chemoembolization with drug-eluting beads Combined With lenvatinib and tislelizumab	Drug: HAIC; FOLFOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 100 mg/m2 infusion for 2 hours; calcium levofolinate, 200 mg/m2 infusion for 1 hours; and 5-FU, 400 mg/m2 bolus infusion and then 2400 mg/m2 continuous infusion over 46 h.; Other Names: HAIC+Lenvatinib+tislelizumab; Drug: Lenvatinib; 12 mg/d for bodyweight ⩾ 60 kg or 8 mg/d for bodyweight <60 kg; Other Names: Targeted therapy; Drug: D-TACE; CalliSpheres (100-300 µm) loaded with pirarubicin for transarterial chemombolization: Typically, one vial of the beads was loaded with 60 mg pirarubicin. If blushed tumors is still visible after the embolization with one vial of beads, regular microspheres (8spheres) with diameters of 100-700 μm are additionally injected.; Other Names: D-TACE+lenvatinib+tislelizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Response	The tumor responses were evaluated by measuring the longest diameter of target lesions according to response evaluation criteria in solid tumors.(RECIST) version 1.1	6-8 weeks
Overall survival	Overall survival (OS) was measured from the initiation of transarterial therapy to the date of death or the last follow-up.	24months
Progression-free survival	Progression-free survival (PFS) was measured from the initiation of transarterial therapy to the time of progression or recurrence or last follow-up	24 months
Cancer embolism withdraws	The degree of thrombosis withdrawal of the portal vein or hepatic vein(VP1-VP4 or I-IV).	6-8 weeks

Collaborators and Investigators

• Sponsor: Wen Li

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Lenvatinib; Immune Checkpoint Inhibitors
• Other Study ID Numbers: 11011 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No