Recruiting

Targeted Therapy, Immunotherapy, and Palliative Hepatectomy for Advanced Hepatocellular Carcinoma

Study Aim

This study aims to evaluate the effectiveness of targeted therapy, immunotherapy, and palliative hepatectomy in treating advanced hepatocellular carcinoma, by measuring the proportion of patients whose tumors shrink to a certain amount and maintain for a certain period of time.

What is being tested

Palliative Hepatectomy

+ Durvalumab

+ Lenvatinib

ProcedureDrug

Who is being recruted

From 18 to 75 Years

+28 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: June 2024

See protocol details

Summary

Principal SponsorZhiyong Huang

Study ContactZhiyong HuangMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2024

Actual date on which the first participant was enrolled.

This clinical study is exploring a new approach to treating advanced liver cancer, known as hepatocellular carcinoma. It involves combining different types of treatments to see if they can work better together. The study focuses on patients with liver cancer that has reached an advanced stage, specifically stage B or C according to a particular staging method called the Barcelona Clinic Liver Cancer classification. The hope is that this combination of treatments might improve outcomes for patients who have limited options with their current treatment plans. Participants in this study receive a combination of therapies, including local treatments like transcatheter arterial chemoembolization (TACE) or yttrium-90 radiation therapy. These are paired with medications called Lenvatinib and Durvalumab that target cancer cells and boost the immune system. After three months, doctors check to see how the cancer has responded. If the cancer is still growing or not responding well, a surgery called palliative hepatectomy is performed to help relieve symptoms. However, if the cancer is responding well, participants continue with their current treatment. Treatment is carefully managed, as patients must stop taking the targeted drugs and immunotherapy about a week before any surgery.

Official TitlePalliative Hepatectomy Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma

NCT06470256

Principal SponsorZhiyong Huang

Study ContactZhiyong HuangMore contacts

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

50 patients to be enrolled

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

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

Patients aged 18 to 75 years (inclusive).

No prior systemic antitumor treatment or surgical treatment.

Clinical or pathological diagnosis of hepatocellular carcinoma (HCC).

The primary liver lesion is mainly isolated liver tumors, with a tumor burden exceeding 90% of the total tumor burden, and technically capable of complete resection. Simultaneously merging ① intrahepatic metastasis: the number of metastatic tumors is ≥ 3 and the sum of tumor diameters is ≤ 3cm; Or ② Extrahepatic metastasis: Extrahepatic metastasis does not exceed one organ, metastatic tumors do not exceed three, and the total diameter does not exceed 3cm. Or ③ if combined with portal vein tumor thrombus or hepatic vein tumor thrombus, it can be removed or completely removed together with the main tumor, and the tumor thrombus does not enter the superior mesenteric vein or inferior vena cava.

Show More Criteria

17 exclusion criteria prevent from participating

Other reasons that the investigator considers unsuitable for enrollment.

History of or concurrent active malignancy (excluding malignancies that have been cured for over 5 years or in situ cancers that can be completely cured with adequate treatment).

Presence of central nervous system metastasis or a history of brain metastasis.

History of organ transplantation.

Show More Criteria

Study Plan

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

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Reduce tumor burden by over 90% through palliative hepatectomy . Starting two weeks post-surgery, patients began intravenous infusions of the PD-L1 monoclonal antibody, Durvalumab, at a dosage of 1500 mg every three weeks. Three weeks post-surgery, patients commenced oral administration of the targeted therapy, Lenvatinib, with a dosage based on body weight: 8 mg (≤60 kg) or 12 mg (\>60 kg), once daily. The use of Durvalumab and Lenvatinib continued until the primary endpoint or other criteria specified in the protocol for terminating the study treatment.

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 1 location

Recruiting

Tongji Hospital

Wuhan, ChinaOpen Tongji Hospital in Google Maps

Recruiting

One Study Center