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

Sponsor
Zhiyong Huang
Study ID
NCT06470256
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Palliative Hepatectomy — PROCEDURE
    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.
  • Durvalumab — DRUG
    Starting two weeks post-surgery, patients began intravenous infusions of the PD-L1 monoclonal antibody, Durvalumab.
  • Lenvatinib — DRUG
    Three weeks post-surgery, patients commenced oral administration of Lenvatinib.

Study Details

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.

Key Dates

Start date
Jun 1, 2024
Status verified
Jun 2024
Primary completion
Jun 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 6 weeks after first dose of Durvalumab ]

Central Contacts

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