Efficacy and Safety of Radiotherapy in Oligoprogressive HCC Following First-line PD-1 Therapy
Eligible age
18–75 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Shanghai Zhongshan Hospital
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 1. Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma;
- ✕ 2. History of hepatic encephalopathy or liver transplantation;
- ✕ 3. Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage. Only a small amount of pleural effusion, ascites and pericardial effusion without symptoms could be included;
- ✕ 4. Untreated hepatitis infection: HBV DNA\>2000IU/mlor104 copy/ml, HCV RNA\> 103copy/ml, both HbsAg and anti-HCV body are positive;
- ✕ 5. Evidence with active central nervous system (CNS) metastases. Patients can be included if the CNS metastasis can be treated and the neurological symptoms can be restored to a level of \<=1 degree of CTCAE (except for residual signs or symptoms associated with CNS treatment) for at least 2 weeks before the enrollment. In addition, patients must have not be treated with a corticosteroid, or just be treated with a stable dose of \<= 10 mg prednisone/day (or equivalent dose) or with a dose reduced to 10 mg prednisone/day;
- ✕ 6. In the past six months, there was a history of gastrointestinal perforation and/or fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive intestinal resection (partial or extensive intestinal resection with chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea;
- ✕ 7. History of symptomatic interstitial lung disease or other conditions that may cause confusion when discovering or managing suspicious drug-related lung toxicity;
- ✕ 8. Evidence of active pulmonary tuberculosis (TB). Patients diagnosed with active tuberculosis infection within 1 year should be excluded even if they have been treated;
Source: ClinicalTrials.gov · NCT06870942 · last updated 2025-03-11