NCT06571396

Perioperative Risk of Immunotherapy Based Neoadjuvant and Conversion Therapy for Hepatocellular Carcinoma

Perioperative Risk Factors and Nomograms for Participants With Hepatocellular Carcinoma Receiving Neoadjuvant Immunotherapy or Conversion Therapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to retrospectively collect a cohort of participants with hepatocellular carcinoma who received immunotherapy-based neoadjuvant/translational 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 neoadjuvant/conversion 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.

Conditions

• Carcinoma, Hepatocellular
• Immunotherapy

Timeline

• Start date: 2014-04-01
• Primary completion: 2025-08-01
• Completion: 2026-08-03
• First posted: 2024-08-26
• Last updated: 2024-08-26

Locations

1 site across 1 country: China