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NOT YET RECRUITING
NCT06981858
PHASE2

A Single-Arm Exploratory Study of Enlansibumab Sequentially Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer

Sponsor: Chongqing University Cancer Hospital

View on ClinicalTrials.gov

Summary

This is a prospective , single - arm clinical study , aiming to evaluate the efficacy and safety of Enlansibumab sequential concurrent chemoradiotherapy in locally advanced cervical cancer. Patients will first receive one cycle of Enlansibumab monotherapy (360 mg, 60 - min IV infusion on day 1, every 3 weeks). After one treatment cycle (3 weeks), they'll undergo imaging assessment. Then, they'll have Enlansibumab (360 mg, 60 - min IV infusion on day 1, every 3 weeks for two cycles) combined with concurrent chemoradiotherapy. Chemotherapy involves cisplatin (40 mg/m²) or carboplatin (AUC2) via IV infusion, weekly (±7 days), with five planned cycles. Investigators may add a sixth platinum - based chemotherapy cycle if needed. Radiotherapy comprises EBRT and BT and must be completed within eight weeks of treatment initiation. The total prescription dose of EBRT combined with BT should have an EQD2 of ≥8000 cGy, with adjustments based on tumor regression. After concurrent chemoradiotherapy, treatment ends. An imaging assessment occurs around seven days (±3 days) later. Then, the follow - up phase begins, including final, safety, and survival follow - ups, continuing until patients are lost to follow-up, the follow-up ends, or they die.

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2025-05-15

Completion Date

2029-02-01

Last Updated

2025-05-21

Healthy Volunteers

No

Interventions

DRUG

Enlonstobart Injection

Sequential Enlonstobart Injection with concurrent chemoradiotherapy