Palliative Hepatectomy Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma

Summary

Hepatocellular carcinoma (HCC) is one of the most common malignant tumors and the leading cause of cancer-related death worldwide. Surgical resection has always been the best hope for long-term survival of patients with HCC. However, due to the fact that most patients are already in the middle and late stages of treatment, only about 20% of patients have the opportunity to undergo surgical resection. Palliative cytoreductive surgery has been used in the treatment of a variety of malignant tumors, but it is not recommended for the treatment of HCC. Under the premise of targeted therapy and immunotherapy, palliative hepatectomy can reduce tumor burden and may further improve the therapeutic effect of HCC. The aim of this study is to explore whether palliative hepatectomy combined with targeted therapy and immunotherapy can improve the therapeutic effect of advanced HCC, ultimately prolong the survival time of patients, and provide a new treatment direction for patients with advanced HCC.

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

PROCEDURE

Palliative Hepatectomy

Patients will receive TACE, HAIC, or 90Y-SIRT combined with Lenvatinib and Durvalumab. After receiving three months of combined treatment, patients in the SD or PD stage who have poor efficacy evaluated by imaging will undergo palliative hepatectomy. Palliative Hepatectomy:① Intrahepatic metastasis: complete lesion resection of the main tumor on one side of the liver; ② Extrahepatic metastasis: complete lesion resection of intrahepatic lesions; ③ Merge portal vein tumor thrombus or hepatic vein tumor thrombus: remove the tumor thrombus and completely remove the intrahepatic lesions. And reduce the tumor burden by more than 90% through surgical resection.

DRUG

Durvalumab

Starting two weeks post-surgery, patients began intravenous infusions of the PD-L1 monoclonal antibody, Durvalumab.

DRUG

Lenvatinib

Three weeks post-surgery, patients commenced oral administration of Lenvatinib.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Zhongnan Hospital

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Taihe Hospital

  collaborator OTHER

• Hubei Cancer Hospital

  collaborator OTHER

• Xiangyang Central Hospital

  collaborator OTHER

• Wuhan Central Hospital

  collaborator OTHER

• Zhiyong Huang

  lead OTHER

Principal Investigators

• Zhiyong Huang · Tongji Hospital

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

2024-06-01

Primary Completion

2027-06-01

Completion

2028-06-01

Countries

• China

Study Locations