Radiotherapy + Sintilimab + Bevacizumab Biosimilar for uHCC With PVTT (NCT05530785) | Clinical Trial Compass
UnknownNot Applicable
Radiotherapy + Sintilimab + Bevacizumab Biosimilar for uHCC With PVTT
China35 participantsStarted 2022-08-01
Plain-language summary
This study was a prospective, single-arm, single-center, phase II exploratory clinical study. To investigate the efficacy and safety of radiotherapy combined with sintilimab and bevacizumab biosimilar in the treatment of unresectable hepatocellular carcinoma with portal vein tumor thrombus.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Hepatocellular carcinoma confirmed by histology/cytology, or patients with cirrhosis and meet the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for HCC
✓. Child-pugh grade A or B (≤7 points)
✓. A score of 0-1 according to the Eastern Cooperative Oncology Group Physical Status Score (ECOG PS score);
✓. Barcelona stage C; Inamicable for radical surgical resection or refusal of surgery without extra-hepatic metastases; Portal vein tumor thrombus (PVTT) was diagnosed by enhanced CT or enhanced MRI (type VP1 to VP3).
✓. Had not received systemic therapy or radiotherapy before; Or disease progression after surgical resection or local treatment (without radiotherapy);
✓. At least one measurable or evaluable lesion according to the response evaluation criteria for solid tumors, version 1.1 (RECIST V1.1); Or measurable lesions that had clearly progressed after local treatment (based on RECIST V1.1 criteria).
✓. Patients with liver lesions and/or portal vein tumor thrombus lesions were treated with radiotherapy
Exclusion criteria
✕. Previous histological/cytological diagnosis included fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, and other components.
✕. The area to be treated had been previously treated with radiotherapy