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A Clinical Study of Tislelizumab Combined With TACE and Lenvatinib in the Neoadjuvant Treatment of Resectable HCC

NCT06003673 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-10-24

No results posted yet for this study

Summary

In order to improve the R0 resection rate, reduce distant metastasis, and lower postoperative recurrence, there is a growing exploration of surgical treatments for hepatocellular carcinoma (HCC), including preoperative neoadjuvant therapy and postoperative adjuvant therapy. This study is a single-arm, prospective, exploratory clinical trial aimed at evaluating the effectiveness and safety of combining tislelizumab with transarterial chemoembolization (TACE) and lenvatinib as neoadjuvant therapy for resectable CNLC stage IIa-IIb HCC patients. The primary research endpoint of this study is recurrence-free survival (RFS). A total of 20 Chinese HCC patients with stage IIa-IIb and tumors deemed resectable by the investigator are enrolled in this study. For stage IIa patients, the inclusion criteria require meeting any of the following: unclear tumor boundaries, proximity to blood vessels, or suspicious residual margins. The enrolled patients undergo 2 cycles of neoadjuvant therapy, with each cycle consisting of treatment every 3 weeks. On the first day of the first treatment cycle, conventional transarterial chemoembolization (TACE) is performed, and concomitant intravenous infusion of tislelizumab at a dose of 200mg is given, followed by oral administration of lenvatinib at a dose of 8/12mg once daily. On the first day of the second cycle, tislelizumab is again administered intravenously at a dose of 200mg, TACE is not repeated, and lenvatinib treatment is continued. Within 2-4 weeks after the completion of neoadjuvant therapy, the investigator evaluates the tumor's suitability for surgical resection based on comprehensive assessment of imaging results. Subsequently, tumor resection surgery is performed on eligible patients, followed by survival and safety follow-up for the patients.

Conditions

  • Hepatocellular Carcinoma Resectable

Interventions

COMBINATION_PRODUCT

neoadjuvant therapy

The enrolled patients undergo 2 cycles of neoadjuvant therapy, with each cycle consisting of treatment every 3 weeks. On the first day of the first treatment cycle, conventional transarterial chemoembolization (TACE) is performed, and concomitant intravenous infusion of tislelizumab at a dose of 200mg is given, followed by oral administration of lenvatinib at a dose of 8/12mg once daily. On the first day of the second cycle, tislelizumab is again administered intravenously at a dose of 200mg, TACE is not repeated, and lenvatinib treatment is continued. Within 2-4 weeks after the completion of neoadjuvant therapy, the investigator evaluates the tumor's suitability for surgical resection based on a comprehensive assessment of imaging results. Subsequently, eligible patients undergo tumor resection surgery, followed by follow-up for survival and safety monitoring.

Sponsors & Collaborators

  • First Affiliated Hospital of Fujian Medical University

    lead OTHER

Principal Investigators

  • Zhang Zhibo, PhD · First Affiliated Hospital of Fujian Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-07-01
Completion
2025-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06003673 on ClinicalTrials.gov