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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, without significant organ dysfunction.

• Child-Pugh class A.

• HBV-DNA less than 1\*10\^5 copies/ml and undergoing antiviral therapy.

• Important organ functions meeting the following criteria: White Blood Cell (WBC) ≥2.5 × 10\^9/L ;Platelet (PLT) ≥75 × 10\^9/L;Hemoglobin (HB) ≥ 9g/dL;Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3\*ULN, Total Bilirubin ≤ 3\*ULN; International Normalized Ratio (INR) ≤ 1.5\*ULN; Prothrombin Time ≤ 1.5\*ULN; Creatinine ≤ 1.5\*ULN.

• Expected survival time of more than 3 months.

⁃ According to the RECIST v1.1 standard, postoperative patients with at least one longest diameter of 1 cm or more measurable tumors.

⁃ Willing to provide informed consent.

Locations
Other Locations
China
Tongji Hospital
RECRUITING
Wuhan
Contact Information
Primary
Zhiyong Huang
Zyhuang126@126.com
86-13995507729
Backup
Erlei Zhang
baiyu19861104@163.com
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 50
Treatments
Experimental: Palliative Hepatectomy Combined With Targeted Therapy and Immunotherapy
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.
Related Therapeutic Areas
Sponsors
Collaborators: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hubei Cancer Hospital, Wuhan Central Hospital, Renmin Hospital of Wuhan University, Zhongnan Hospital, Taihe Hospital, Xiangyang Central Hospital
Leads: Zhiyong Huang

This content was sourced from clinicaltrials.gov