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ACTIVE NOT RECRUITING
NCT06419673
PHASE2

Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

Summary

This study is a prospective, multicenter, randomized, open controlled clinical trial aimed at evaluating the effectiveness and safety of serplulimab plus chemoradiotherapy in FIGO 2018 stage III or IVA cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma patients who have not received prior treatment.

Official title: Induced and Concurrent Serplulimab Plus Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for Stage III-IVA Cervical Cancer: a Prospective, Multicenter, Randomized, Open Controlled Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-05-01

Completion Date

2028-05-31

Last Updated

2024-05-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

Serplulimab

Serplulimab will be administered by intravenous infusion at a dose of 300mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

DRUG

Cisplatin

IV infusion

DRUG

Carboplatin

IV infusion

RADIATION

Brachytherapy and External Beam Radiotherapy

Brachytherapy and External Beam Radiotherapy

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China