Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis
Trial Parameters
Brief 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. Maintenance therapy is continued until disease progression or intolerance. The primary endpoint is median overall survival (mOS), and secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and toxicity.
Eligibility Criteria
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 significant abnormalities in the electrocardiogram, no apparent heart failure, and no contraindications for anti-PD-1 treatment; 10. CRE, BUN within 2.5 times the normal upper limit; 11. Hb ≥ 50g/L, ANC ≥ 0