NCT06003673

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

Status unknown Phase 4 Last updated 24 October 2023

What this trial tests

Phase 4 trial testing neoadjuvant therapy in Hepatocellular Carcinoma Resectable in 20 participants. Status unknown.

Timeline

1 July 2023

Primary endpoint
1 July 2024

1 July 2025

Quick facts

Lead sponsor	First Affiliated Hospital of Fujian Medical University
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 July 2023
Primary completion	1 July 2024
Estimated completion	1 July 2025
Sites	1 location across China

Drugs / interventions tested

• neoadjuvant therapy — full drug profile →

Conditions studied

• Hepatocellular Carcinoma Resectable — all drugs for Hepatocellular Carcinoma Resectable →

Sponsor

First Affiliated Hospital of Fujian Medical University

Who can join

Adults 18 to 75, any sex, with Hepatocellular Carcinoma Resectable. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neoadjuvant systemic therapy for hepatocellular carcinoma.
   Chick RC, Ruff SM, Pawlik TM. · · 2024 · cited 16× · PMID 38495884 · DOI 10.3389/fimmu.2024.1355812
2. Neoadjuvant systemic therapy for hepatocellular carcinoma: challenges and opportunities-a narrative review.
   Zhang Y, Yue S, Zhang B, Chen X, et al · · 2025 · cited 2× · PMID 41104208 · DOI 10.21037/hbsn-24-175
3. Neoadjuvant therapy for hepatocellular carcinoma-priming precision innovations to transform HCC treatment.
   Goodsell KE, Tao AJ, Park JO. · · 2025 · cited 2× · PMID 40115081 · DOI 10.3389/fsurg.2025.1531852
4. Exploring potential predictive biomarkers through historical perspectives on the evolution of systemic therapies into the emergence of neoadjuvant therapy for the treatment of hepatocellular carcinoma.
   Wang C, Wei F, Sun X, Qiu W, et al · · 2024 · PMID 38993637 · DOI 10.3389/fonc.2024.1429919