Clinical trial · Observational
Therapeutic Effects of Immuno-targeted Therapy Combined With or Without RT for HCC
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
NCT06639971CI-TRIAL-00081624RIO-HCCnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- ITR group
- description
- hepatocellular carcinoma patients treated with immunotherapy and targeted therapy combined with radiotherapy
- label
- IT group
- description
- hepatocellular carcinoma patients treated with immunotherapy and targeted therapy alone
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- Up to 2 years
- description
- 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.
Secondary outcomes (2)
- measure
- Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDZhong 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. PMID 34094988
- BACKGROUNDSu 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. PMID 36211350
- BACKGROUNDRen 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. PMID 34143971