A Prospective, Single-arm Study on Nimotuzumab Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced High-risk Squamous Cell Carcinoma of the Cervix (CC11)

NCT06771596 Phase 2 ACTIVE_NOT_RECRUITING

The efficacy and safety of nimotuzumab in the treatment of high-risk, locally advanced squamous cell carcinoma of the cervix.

Details

Lead sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	43
Start date	2021-05-12
Completion	2025-09

Conditions

• Uterine Cervical Neoplasms

Interventions

• Nimotuzumab Injection

Primary outcomes

• Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) — 24 months
  PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD.

Countries

China