RecruitingPhase 1NCT06470256

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


Sponsor

Zhiyong Huang

Enrollment

50 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether removing the main liver tumor (even when the cancer has spread in limited ways) combined with targeted therapy and immunotherapy can help people with advanced liver cancer live longer. **You may be eligible if...** - You are 18 to 75 years old with a clinical or confirmed diagnosis of liver cancer (hepatocellular carcinoma) - You have not had any prior cancer treatment (no surgery or systemic therapy) - The main liver tumor makes up over 90% of your total cancer burden and can be completely removed - Spread outside the main tumor is limited: either a few small liver spots, a limited number of small tumors in one other organ, or a removable blood vessel tumor clot **You may NOT be eligible if...** - You have had any previous cancer treatment - The spread is too extensive to allow meaningful surgery - You have poor liver or kidney function - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPalliative 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.

DRUGDurvalumab

Starting two weeks post-surgery, patients began intravenous infusions of the PD-L1 monoclonal antibody, Durvalumab.

DRUGLenvatinib

Three weeks post-surgery, patients commenced oral administration of Lenvatinib.


Locations(1)

Tongji Hospital

Wuhan, Hubei, China

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NCT06470256


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