Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-06 @ 12:53 PM
Study NCT ID:
NCT06470256
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palliative Hepatectomy Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma
Sponsor:
Zhiyong Huang
Organization:
Study Overview
Official Title:
Palliative Hepatectomy Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: