An observational study in Hepatocellular Carcinoma (HCC), sponsored by Shanghai Zhongshan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Shanghai Zhongshan Hospital · Observational
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?
A retrospective analysis will be conducted on the clinical data of patients with hepatocellular carcinoma who underwent combined immunotherapy and targeted therapy with radiotherapy, as well as those who received immunotherapy and targeted therapy alone, at Zhongshan Hospital, Fudan University, from January 1, 2017, to December 31, 2023. The pmary objective is to assess the disparities in treatment efficacy and treatment-related adverse events between the two cohorts.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 500 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
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This study includes HCC patients who received targeted therapy and immunotherapy at Zhongshan Hospital affiliated with Fudan University between January 1, 2017, and December 31, 2023. Tumor staging criteria included CNLC stage IIIa or IIIb hepatocellular carcinoma with concurrent vascular invasion or extrahepatic metastasis, CNLC stage IIb hepatocellular carcinoma presenting as a localized lesion unsuitable for surgical resection or transarterial chemoembolization (TACE), presence of main portal vein or inferior vena cava tumor thrombus, or disease progression after multiple local treatments.
Exclusion Criteria:
hepatocellular carcinoma patients treated with immunotherapy and targeted therapy combined with radiotherapy
hepatocellular carcinoma patients treated with immunotherapy and targeted therapy alone
Progression Free Survival
Progression free survival is defined as the duration between the date of of initial administration of targeted therapy and immunotherapy to the date of first documented progression or death due to any cause or date of last follow-up, whichever is earlier.
Time frame: Up to 2 years
Overall Survival
Overall survival is defined as the duration between the date of initial administration of targeted therapy and immunotherapy to the date of death due to any cause or the date of last follow-up, whichever is earlier.
Time frame: Up to 2 years
Treatment-related Adverse Effects
At baseline and at subsequent follow up till 2 years based on Common Terminology Criteria for Adverse Events 5.0
Time frame: Up to 2 years
Plan to share: No — The IPD will not be shared with other researchers in order to protect patients' privacy.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Shanghai Zhongshan Hospital