30
Participants
Start Date
September 1, 2025
Primary Completion Date
June 30, 2026
Study Completion Date
December 31, 2028
radiotherapy
The patients receive pelvic radiotherapy: Intensity-Modulated Radiation Therapy (IMRT) or Volumetric Modulated Arc Therapy (VMAT), with a total dose of 25 Gy delivered in 5 fractions. Radiotherapy is to start on day 1 and to finish on day 5.
Ivonescimab (20mg/kg Q3W)
The first dose of vonescimab (AK112) was administered 1 week after the completion of radiotherapy. Ivonescimab (AK112) was initiated at a dose of 20 mg/kg via intravenous infusion on Day 1 of each 21-day cycle, for a total of 6 cycles.
Non-operative Management
Subjects who achieve cCR after radiation and 6 cycles treatment of Ivonescimab can, after discussion with the local investigator, decline surgery and opt for a non-operative management.
Surgery
For patients who do not achieve cCR at the end of 6 cycles treatment of Ivonescimab, TME surgery is recommended.
Collaborators (1)
Akeso
INDUSTRY
Zhejiang Cancer Hospital
OTHER