34
Participants
Start Date
December 1, 2024
Primary Completion Date
December 1, 2025
Study Completion Date
December 1, 2028
Toripalimab
"Induction chemo-immunotherapy (platinum-based tri-weekly regimen)~* Paclitaxel 175 mg/m² IV on day 1~* Cisplatin 50 mg/m² IV on day 1 or carboplatin AUC 4-5 IV on day 1~* Toripalimab 240 mg IV on day 1, administered immediately before each chemotherapy infusion Cycle length: every 3 weeks Number of cycles: 2 Concurrent chemoradiotherapy (weekly regimen)~* Radiation therapy delivered according to institutional protocol~* Cisplatin 40 mg/m² IV once weekly~* Toripalimab 240 mg IV on day 1 of every 3-week cycle, given before chemotherapy Cycle length: every 3 weeks during radiotherapy~Maintenance immunotherapy~• Toripalimab 240 mg IV on day 1 every 3 weeks (Q3W) Duration: 1 year (total 13 cycles)"
Pelvic External-Beam Radiotherapy (EBRT)
"* PTV: 6 MV photons, 1.80 Gy per fraction × 28 fractions = 50.4 Gy.~* PGTVnd: 6 MV photons, 2.14 Gy per fraction × 28 fractions = 59.92 Gy. Brachytherapy:Dose prescriptions~* Dose: 7.00 Gy per fraction × 4 fractions = 28.0 Gy."
RECRUITING
Tianjin Medical University Cancer Institute&Hospital, Tianjin
Tianjin Medical University Cancer Institute and Hospital
OTHER