Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571396
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Perioperative Risk of Immunotherapy Based Neoadjuvant and Conversion Therapy for Hepatocellular Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Perioperative Risk Factors and Nomograms for Participants With Hepatocellular Carcinoma Receiving Neoadjuvant Immunotherapy or Conversion Therapy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to retrospectively collect a cohort of participants with hepatocellular carcinoma who received immunotherapy-based neoadjuvanttranslational treatment A multi-dimensional and multi-method analysis plan will be adopted The goal is to provide solutions for better application of neoadjuvant immunotherapy and to offer better evidence for conducting prospective clinical research on hepatocellular carcinoma
Detailed Description:
Hepatocellular carcinoma HCC is indeed a significant health concern especially in regions like China where its incidence and mortality rates are notably high Radical resection is the main method for curing HCC However about 64 of HCC participants are diagnosed at mid to late stages making surgical resection unsuitable as the first choice Additionally the short-term recurrence rate after HCC surgery is relatively high with a five-year recurrence and metastasis rate reaching 70 Therefore increasing the radical resection rate and reducing the postoperative recurrence rate are key measures to improve prognosis
With the development of tumor genomics and immunology systematic treatment based on immune checkpoint inhibitors ICIs has shown remarkable efficacy in improving HCC prognosis The application of ICIs in perioperative treatment of solid tumors can effectively reduce tumor burden while expanding the immune effect of tumor antigens thereby increasing resection rates and reducing recurrence rates
Currently neoadjuvant immunotherapy has achieved good treatment outcomes in lung cancer esophageal cancer and gastric cancer However the increased antitumor treatment may lead to potential treatment side effects For neoadjuvant immunotherapy in solid tumors preoperative treatment can pose perioperative risks such as tissue edema adhesions and excessive bleeding during surgery Due to the hidden effects of some immune therapy adverse reactions these perioperative risks require particular attention and research
Neoadjuvant immunotherapy for HCC is still in its infancy with a limited number of cases reported by various centers and there are currently no large-sample clinical studies available
The investigators intend to establish a cohort of HCC participants undergoing neoadjuvantconversion treatment It will employ a multidimensional and multi-method analysis plan to systematically investigate the perioperative risks associated with immunotherapy in these participants aiming to provide solutions for better application of neoadjuvant immunotherapy in HCC while also offering improved evidence for the conduct of prospective clinical research in HCC
With the development of tumor genomics and immunology systematic treatment based on immune checkpoint inhibitors ICIs has shown remarkable efficacy in improving HCC prognosis The application of ICIs in perioperative treatment of solid tumors can effectively reduce tumor burden while expanding the immune effect of tumor antigens thereby increasing resection rates and reducing recurrence rates
Currently neoadjuvant immunotherapy has achieved good treatment outcomes in lung cancer esophageal cancer and gastric cancer However the increased antitumor treatment may lead to potential treatment side effects For neoadjuvant immunotherapy in solid tumors preoperative treatment can pose perioperative risks such as tissue edema adhesions and excessive bleeding during surgery Due to the hidden effects of some immune therapy adverse reactions these perioperative risks require particular attention and research
Neoadjuvant immunotherapy for HCC is still in its infancy with a limited number of cases reported by various centers and there are currently no large-sample clinical studies available
The investigators intend to establish a cohort of HCC participants undergoing neoadjuvantconversion treatment It will employ a multidimensional and multi-method analysis plan to systematically investigate the perioperative risks associated with immunotherapy in these participants aiming to provide solutions for better application of neoadjuvant immunotherapy in HCC while also offering improved evidence for the conduct of prospective clinical research in HCC
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: