NCT06870942 Efficacy and Safety of Radiotherapy in Oligoprogressive HCC Following First-line PD-1 Therapy
| NCT ID | NCT06870942 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | HCC - Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2022-07-28 |
| Primary Completion | 2024-11-30 |
Trial Parameters
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Brief Summary
Immune checkpoint inhibitors (ICIs) have significantly improved the survival outcomes of HCC patients. However, a considerable proportion of patients eventually experience disease progression due to the development of resistance. Among these, oligoprogression is a common manifestation, occurring in 10-55.3% of advanced cancer patients. Local therapy, especially radiotherapy (RT), has been increasingly considered in the setting of oligoprogression to overcome ICIs resistance and delay the need to change systemic therapy. Therefore, this study aimed to explore the efficacy and safety of RT in oligoprogressive HCC following first-line PD-1 therapy.
Eligibility Criteria
Inclusion Criteria: 1. Diagnosis of hepatocellular carcinoma (HCC) based on either histopathologic or cytologic findings or a diagnosis of cirrhosis and HCC with classical imaging characteristics; 2. HCC patients with oligoprogression after first-line PD-1 therapy ; 3. Stable Disease for at least 3 months after first-line PD-1 therapy ; 4. Oligoprogressive disease in 5 or fewer lesions and 3 or fewer organs 5. Tumor staged as BCLC stage C 6. ECOG performance status: 0-1. 7. Life expectancy \>=6 months. 8. No history of irradiation. 9. aged 18 to 75 years old are eligible. 10. Patients must be able to understand and willing to sign a written informed consent document. 11. Female patients within childbearing age or male patients whose sexual partners are women within childbearing age need to take effective contraceptive measures throughout the treatment period and 6 months after the treatment. Exclusion Criteria: 1. Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carc
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