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| ID | Type | Description | Link |
|---|---|---|---|
| B2024-336R | Other Identifier | Zhongshan Hospital, Fudan University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITR group | hepatocellular carcinoma patients treated with immunotherapy and targeted therapy combined with radiotherapy | ||
| IT group | hepatocellular carcinoma patients treated with immunotherapy and targeted therapy alone |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years |
| Treatment-related Adverse Effects |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qianqian Zhao | Contact | +8618217008910 | zhao.qianqian1@zs-hospital.sh.cn | |
| Zhaochong Zeng | Contact | +8613817076800 | zeng.zhaochong@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34094988 | Background | Zhong L, Wu D, Peng W, Sheng H, Xiao Y, Zhang X, Wang Y. Safety of PD-1/PD-L1 Inhibitors Combined With Palliative Radiotherapy and Anti-Angiogenic Therapy in Advanced Hepatocellular Carcinoma. Front Oncol. 2021 May 19;11:686621. doi: 10.3389/fonc.2021.686621. eCollection 2021. | |
| 36211350 | Background | Su K, Guo L, Ma W, Wang J, Xie Y, Rao M, Zhang J, Li X, Wen L, Li B, Yang X, Song Y, Huang W, Chi H, Gu T, Xu K, Liu Y, Chen J, Wu Z, Jiang Y, Li H, Zeng H, Wang P, Feng X, Chen S, Yang B, Jin H, He K, Han Y. PD-1 inhibitors plus anti-angiogenic therapy with or without intensity-modulated radiotherapy for advanced hepatocellular carcinoma: A propensity score matching study. Front Immunol. 2022 Sep 23;13:972503. doi: 10.3389/fimmu.2022.972503. eCollection 2022. |
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The IPD will not be shared with other researchers in order to protect patients' privacy.
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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At baseline and at subsequent follow up till 2 years based on Common Terminology Criteria for Adverse Events 5.0 |
| Up to 2 years |
| 34143971 | Background | Ren Z, Xu J, Bai Y, Xu A, Cang S, Du C, Li Q, Lu Y, Chen Y, Guo Y, Chen Z, Liu B, Jia W, Wu J, Wang J, Shao G, Zhang B, Shan Y, Meng Z, Wu J, Gu S, Yang W, Liu C, Shi X, Gao Z, Yin T, Cui J, Huang M, Xing B, Mao Y, Teng G, Qin Y, Wang J, Xia F, Yin G, Yang Y, Chen M, Wang Y, Zhou H, Fan J; ORIENT-32 study group. Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2-3 study. Lancet Oncol. 2021 Jul;22(7):977-990. doi: 10.1016/S1470-2045(21)00252-7. Epub 2021 Jun 15. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |