NCT05437692

Zimberelimab Combined With Concurrent Radiotherapy and Chemotherapy for Locally Advanced Cervical Cancer

A Prospective, Single Arm, Phase II Clinical Study on the Treatment of Locally Advanced Cervical Cancer (Ⅱ B to Ⅳ a) With Zimberelimab Combined With Concurrent Radiotherapy and Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single arm, phase II clinical study on the treatment of locally advanced cervical cancer (Ⅱ B to Ⅳ a) with Zimberelimab combined with concurrent radiotherapy and chemotherapy.

Detailed description

This study will include 19 patients with locally advanced cervical cancer to explore the efficacy and safety of Zimberelimab in combination with concurrent radiotherapy for them.

Conditions

• Locally Advanced Cervical Cancer

Interventions

Type	Name	Description
DRUG	zimberelimab combined With concurrent radiotherapy and chemotherapy	zimberelimab: 240 mg Q2W Intravenous drip，The maximum duration of medication shall not exceed one years; chemotherapy: Starting from the first week of radiotherapy and chemotherapy, cisplatin 40mg/m2 and paclitaxel 35mg/m2 were given intravenously for 30-60min; Radiotherapy: intensity modulated radiation therapy (IMRT) was used for external irradiation. The total dose of pelvic cavity and lymph drainage planning target area (PTV) was 45-50 gy/25-28f. The metastatic lymph nodes should be able to supplement or synchronously push 10-15 Gy; The internal irradiation was started within 2 weeks after the end of external irradiation treatment. The image-guided three-dimensional brachytherapy was used, and 30-40gy was added to make the total dose of point a reach 80-85 Gy, twice a week, 5-6gy each time. All radiotherapy was completed within 8 weeks.

Timeline

• Start date: 2022-07-15
• Primary completion: 2024-07-01
• Completion: 2025-07-01
• First posted: 2022-06-29
• Last updated: 2022-10-12

Locations

1 site across 1 country: China