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

NCT05582278 | Unknown Phase 2 DMC

• 1 other identifier: 11011
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unresectable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

HAIC+lenvatinib+tislelizumab

EXPERIMENTAL

Hepatic Arterial Infusion Chemotherapy Combined With lenvatinib and tislelizumab

Drug: HAIC; Drug: Lenvatinib; Drug: tislelizumab

D-TACE+lenvatinib+tislelizumab

EXPERIMENTAL

Transarterial chemoembolization with drug-eluting beads Combined With lenvatinib and tislelizumab

Drug: D-TACE; Drug: HAIC; Drug: Lenvatinib

Interventions

D-TACE DRUG

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.

Also known as: D-TACE+lenvatinib+tislelizumab

D-TACE+lenvatinib+tislelizumab

HAIC DRUG

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.

Also known as: HAIC+Lenvatinib+tislelizumab

D-TACE+lenvatinib+tislelizumab; HAIC+lenvatinib+tislelizumab

Lenvatinib DRUG

12 mg/d for bodyweight ⩾ 60 kg or 8 mg/d for bodyweight \<60 kg

Also known as: Targeted therapy

D-TACE+lenvatinib+tislelizumab; HAIC+lenvatinib+tislelizumab

tislelizumab DRUG

tislelizumab 200 mg, every 3 weeks.

Also known as: PD-1 inhibitors

HAIC+lenvatinib+tislelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wen Li: lead

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

RECRUITING

MeSH Terms

Interventions

lenvatinib; tislelizumab; Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Wen Li, PhD

CONTACT

18870050597; lw1042@126.com

Lu Fang, PHD

CONTACT

13507911672; fanglu@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 17, 2022
• Study Start: January 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)