NCT06470256

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Zhiyong Huang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective, multicenter, single-arm clinical study aimed at evaluating targeted therapy and immunotherapy combined with palliative hepatectomy for the treatment of advanced hepatocellular carcinoma. Patients who have been assessed as stage B or C of Barcelona Clinic Liver Cancer (BCLC) will receive local treatment (transcatheter arterial chemoembolization (TACE) or transcatheter arterial chemoembolization (HAIC)) or 90Y-SIRT (yttrium-90 selective internal radiation therapy) combined with Lenvatinib and Durvalumab. After receiving three months of combined treatment, patients in the stable disease (SD) or progressive disease (PD) stage who have poor efficacy evaluated by imaging will undergo palliative hepatectomy; patients in the complete response (CR) or partial response (PR) stage after imaging evaluation will be excluded and continue to receive systematic treatment. Patients need to discontinue targeted therapy and immunotherapy one week before surgery.

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-01
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2024-06-24
• Last updated: 2024-06-24

Locations

1 site across 1 country: China