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.
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.
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.
Single group
Palliative Hepatectomy
Procedure/SurgeryPatients 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.
Durvalumab
DrugStarting two weeks post-surgery, patients began intravenous infusions of the PD-L1 monoclonal antibody, Durvalumab.
Lenvatinib
DrugThree weeks post-surgery, patients commenced oral administration of Lenvatinib.
Objective Response Rate (ORR)
ORR refers to the proportion of patients whose tumors shrink to a certain amount and maintain for a certain period of time (6 weeks after first dose of Durvalumab), including CR+PR cases. CR (complete response): disappearance of all target lesions, PR (partial response): reduction of the sum of the length and diameter of the baseline lesions by ≥30%.
Overall Survival (OS)
OS was defined as time from diagnosis to death from any cause or the last follow-up
Progression Free Survival (PFS)
PFS refers to the time from subject enrollment to disease progression according the Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) or death
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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
