Induction Immunotherapy Combined With Chemotherapy Followed by Concurrent Chemoradiotherap and Immunotherapy for Cervical Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2028

Conditions
Cervical Cancer
Interventions
DRUG

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)"

RADIATION

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."

Trial Locations (1)

Unknown

RECRUITING

Tianjin Medical University Cancer Institute&Hospital, Tianjin

All Listed Sponsors
lead

Tianjin Medical University Cancer Institute and Hospital

OTHER