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

Phase 2

Not yet recruiting

• Conditions: LOCALLY ADVANCED CERVICAL CANCERS
• Interventions: Drug: Enlonstobart Injection

• Registration Number: NCT06981858
• Lead Sponsor: Chongqing University Cancer Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study Start: 2025-05-15
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Primary Completion: 2029-02-01
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sequential Enlonstobart Injection with concurrent chemoradiotherapy	Enlonstobart Injection	-

Primary Outcome Measures

Name	Time	Method
1-year PFS rate	1 year after treatment initiation