Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC Wi
This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume \< 700ml or estimated liver-GTV V5 \< 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated i
| Condition(s) | Hepatocellular Carcinoma, Radiotherapy, Pembrolizumab, Tumor Thrombosis |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume \< 700ml or estimated liver-GTV V5 \< 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center. One week before or during the radiotherapy, patients receive concurrent Pembrolizumab at a dose of 200mg. Subsequently, Pembrolizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Pembrolizumab if there are no contraindications. Maintenan |
| Who can participate | Inclusion Criteria: 1. Confirmed clinically or histopathologically as hepatocellular carcinoma, concurrently with portal vein thrombosis or hepatic vein thrombosis; 2. Age 18-90 years; 3. Liver-GTV volume\<700ml or the estimated volume of Liver-GTV receiving less than 5 Gy of irradiation\<300ml but the average dose of Liver-GTV needs to be \<18Gy; 4. Allowed previous treatment including TACE, RFA, surgery, chemotherapy, targeted therapy, etc., but not including ICIs such as anti-PD-1, anti-PD-L1, or anti-PD-L2 therapies; 5. ECOG performance status 0-2, expected survival greater than 1 month; 6. Allowing patients with distant metastases; 7. Child-Pugh A5, A6, B7 and B8; 8. ALT within 2.5 times the normal upper limit; AST within 2.5 times the normal upper limit; TBIL \<60umol/L. 9. No signif |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Lead sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2024-05-01 |
| NCT ID | NCT06389422 |
| Official listing | https://clinicaltrials.gov/study/NCT06389422 |