NCT05151549

A Study of Carilizumab Combined With Concurrent Chemoradiotherapy

A Prospective Evaluation of Carilizumab Combined With Concurrent Chemoradiotherapy in High-risk PD-L1 Positive Stage III-IVA Cervical Cancer One-arm Phase II Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a one-arm phase II clinical study. In patients with stage III-IVA cervical cancer with pelvic lymph nodes \> 2cm, positive para-aortic lymph nodes, or lymph node metastases \> 2, patients with positive PD-L1 expression (CPS score ≥1) were treated with cararizumab combined with conventional concurrent chemoradiotherapy and immunomaintenance therapy for one year. To evaluate the efficacy and safety of carilizumab in combination with concurrent chemoradiotherapy and subsequent maintenance therapy.

Detailed description

The patient received neoadjuvant therapy once every three weeks for a total of seventeen cycles. From the first day of treatment, the patient will undergo concurrent chemoradiation for 5 weeks.The chemotherapy drug is cisplatin or carboplatin every week for 5 weeks. After the end of concurrent chemoradiation, the patient will continue to use camrelizumab as maintenance therapy until one year.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab	200mg/3weeks
DRUG	Cisplatin or Carboplatin	Cisplatin (40mg/m²), every week Carboplatin(AUC 2)

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-12-12
• Completion: 2023-12-12
• First posted: 2021-12-09
• Last updated: 2021-12-09