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NCT06639971

Therapeutic Effects of Immuno-targeted Therapy Combined With or Without RT for HCC

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

The objective of this retrospective cohort study is to investigate the therapeutic effects of combined immunotherapy and targeted therapy, with or without radiotherapy, in patients with hepatocellular carcinoma. The main question it aims to answer is: Does the addition of radiotherapy to immunotherapy and targeted therapy enhance the therapeutic effect more significantly compared to immunotherapy and targeted therapy alone for patients with hepatocellular carcinoma?

Official title: Retrospective Cohort Study on the Therapeutic Effects of Immunotherapy and Targeted Therapy Combined With or Without Radiotherapy for Hepatocellular Carcinoma Based on Real-world Data

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2024-11-01

Completion Date

2024-12-31

Last Updated

2024-10-16

Healthy Volunteers

Conditions

Hepatocellular Carcinoma (HCC)

Inclusion Criteria: 1. Hepatocellular carcinoma confirmed by histopathological/cytopathological examination, or fulfilling the clinical diagnostic criteria for primary liver cancer according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition). 2. Patients with hepatocellular carcinoma who received targeted therapy and immunotherapy at Zhongshan Hospital affiliated with Fudan University from January 1, 2017, to December 31, 2023. 3. Tumor staging meeting at least one of the following criteria: 1) CNLC stage IIIa or IIIb hepatocellular carcinoma with concurrent vascular invasion or extrahepatic metastasis; 2) CNLC stage IIb hepatocellular carcinoma presenting as a localized lesion unsuitable for surgical resection or transarterial chemoembolization (TACE); 3) Presence of main portal vein or inferior vena cava tumor thrombus; 4) Disease progression observed after multiple local treatments (such as surgical resection, TACE, radiofrequency ablation, etc.). 4. Availability of complete clinical and follow-up information. 5. Patients have provided informed consent for donation of biological samples, allowing the donated samples and related information to be used for all medical research purposes. Exclusion Criteria: 1. Contraindications for radiotherapy include hepatocellular carcinoma with diffuse intrahepatic lesions, PS score of 3-4, Child-Pugh C liver function, or the presence of severe underlying medical conditions. 2. Known components of the patient population include cholangiocarcinoma (ICC), mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar carcinoma. 3. Exclusion criteria encompass a history of malignancies other than hepatocellular carcinoma within the past 5 years, except for limited-stage tumors considered cured, such as cervical carcinoma in situ, basal cell carcinoma, and prostate carcinoma in situ. 4. Any other circumstances that the investigator deems unsuitable for participation in the study are also exclusion criteria.

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China