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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhiyong Huang

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

History of surgery in the head, chest, or abdomen within the past six months.

Trial design

Treatments tested in this trial

  • Palliative Hepatectomy
  • Durvalumab
  • Lenvatinib

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Zhiyong Huang

Lead sponsor

Tongji Hospital

Sponsor institution

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

Collaborator

Zhongnan Hospital

Collaborator

Renmin Hospital of Wuhan University

Collaborator

Taihe Hospital

Collaborator

Hubei Cancer Hospital

Collaborator

Xiangyang Central Hospital

Collaborator

Wuhan Central Hospital

Collaborator