Recruiting

TALENP001TACE, Lenvatinib and Cadonilimab for Resectable Hepatocellular Carcinoma

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

From 18 to 75 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: September 2024
See protocol details

Summary

Principal SponsorFujian Provincial Hospital
Study ContactMao-Lin Yan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 30, 2024

Actual date on which the first participant was enrolled.

This study is a single-arm, multi-center, prospective phase II trial aimed at evaluating the efficacy and safety of neoadjuvant therapy with transarterial chemoembolization (TACE) combined with lenvatinib and camrelizumab (triple therapy) in patients with resectable hepatocellular carcinoma (HCC). The study plans to enroll 20 patients. The primary endpoints are major pathological response (MPR) rate and safety, while the secondary endpoints are recurrence-free survival (RFS), objective response rate (ORR), R0 resection rate, and overall survival (OS).

Official TitleNeoadjuvant Transcatheter Arterial Chemoembolization Combined With Lenvatinib Plus Cadonilimab for Resectable Hepatocellular Carcinoma: A Single-Arm Phase II Clinical Trial
NCT06569498
Principal SponsorFujian Provincial Hospital
Study ContactMao-Lin Yan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

11 inclusion criteria required to participate
ECOG performance status 0-1.
Voluntarily join the study and sign the informed consent form.
Male or female patients aged between 18 and 75 years.
Child-Pugh class A.
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12 exclusion criteria prevent from participating
Patients with concomitant psychiatric disorders; history of substance abuse, alcohol, or drug addiction.
Tumor rupture with bleeding or suspected abdominal cavity metastasis.
Previous treatment with any antitumor therapies before enrollment, such as targeted drugs, PD-1/PD-L1/CTLA-4 monoclonal antibodies, surgery, TACE, FOLFOX systemic chemotherapy, radiotherapy, and Huaier granules.
History of allergy to lenvatinib, cadonilimab, or their components.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Recruiting

Fujian provincial hospital

Fuzhou, ChinaOpen Fujian provincial hospital in Google Maps
Recruiting soon

First Affiliated Hospital of Fujian Medical University

Fuzhou, China
Recruiting soon

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, China
Recruiting soon

Zhongshan Hospital of Xiamen University

Xiamen, China
Recruiting
6 Study Centers