Efficacy and Safety of T+A+RAD in HCC

Sponsor
Fudan University
Study ID
NCT05396937
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Multifocal Stereotactic Radiotherapy — RADIATION
    Radiotherapy will be given in combination with atezolizumab and bevacizumab. The patient will be initially treated with atezolizumab and bevacizumab after enrollment. Radiotherapy will be administered to the metastases 1-2 weeks after the completion of the first intravenous injection of atezolizumab and bevacizumab, in the mode of multifocal stereotactic radiotherapy, with a planned total dose to the planned target volume of 25-50 Gy in five divided doses of 5-10 Gy/fraction. Systemic therapy could be continued 48 hours after completion of radiotherapy.
  • Atezolizumab Injection [Tecentriq] — DRUG
    Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21 day cycle
  • Bevacizumab — DRUG
    Bevacizumab will be administered by IV, 10 mg/kg on day 1 of each 21 day cycle

Study Details

This is An Open-label, Single-arm Exploratory Study to determine the efficacy and safety of Multifocal Stereotactic Radiotherapy Combined with Atezolizumab and Bevacizumab in the Treatment of Metastatic Hepatocellular Carcinoma

Key Dates

Start date
Jan 12, 2022
Status verified
May 2022
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

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

Arms

  • Experimental: T+A+RAD

Primary Outcome Measure

Objective response rate, ORR [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

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