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NOT YET RECRUITING
NCT06916117
PHASE2

Neoadjuvant Chemo-immunotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy in LACC

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

Summary

Concurrent chemoradiotherapy -immunotherapy followed by ICI maintenance was proved to improve the PFS by the Keynote-A18 in the LACC patients, and still more than 30% progressed. Neoadjuvant chemo-immunotherapy in LACC resulted in higher pCR rate. This prospective single arm study is to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy in LACC patients.

Official title: A Prospective Single Arm Trial of Neoadjuvant Chemo-immunotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy in Locally Advanced Cervical Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-04-05

Completion Date

2028-12-30

Last Updated

2025-04-08

Healthy Volunteers

No

Interventions

DRUG

Neoadjuvant Chemotherapy (NACT)

Neoadjuvant chemotherapy: The neoadjuvant regimen prior to radiotherapy consists of paclitaxel 135-175 mg/m², cisplatin 75 mg/m², and Sintilimab 200 mg, administered every 3 weeks for 2 cycles. Concurrent chemoradiotherapy: Radical dose to the pelvic concurrent with cisplatin. Consolidative immunotherapy: Following the completion of chemoradiotherapy, Sintilimab consolidation therapy will be administered based on treatment efficacy and the patient's physical condition, for a total of 6 cycles, starting 3-4 weeks after chemoradiotherapy.

Locations (1)

Renji Hospital

Shanghai, Shanghai Municipality, China