Radiotherapy + Sintilimab + Bevacizumab Biosimilar for uHCC With PVTT

Sponsor
Yongchang Zhang
Study ID
NCT05530785
Status
Unknown

Conditions

  • Hepatocellular Carcinoma Non-resectable

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • radiotherapy combined with sintilimab and bevacizumab biosimilar — COMBINATION_PRODUCT
    After signing informed consent, patients received sintilimab 200 mg intravenously on the first day of each cycle, Q3W; Bevacizumab biosimilar 7.5mg/kg was administered intravenously on the first day of each cycle, Q3W; Concurrent radiotherapy (single dose 3-8Gy, times 3-10, total dose 20-50Gy; The duration of radiotherapy was completed between the first administration of sintilimab and the second administration of bevacizumab, but it should be noted that the interval between before and after the administration of sintilimab and bevacizumab was at least 3 days.

Study Details

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.

Key Dates

First listed
Sep 7, 2022
Start date
Aug 1, 2022
Status verified
Sep 2022
Primary completion
Oct 1, 2024
Completion
Oct 1, 2024

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: treatment group
    radiotherapy combined with sintilimab and bevacizumab biosimilar

Primary Outcome Measure

Objective Response rate [ Time Frame: up to 2 years from enrollment ]

Central Contacts

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