NCT05588219

Tislelizumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer

Tislelizumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Single-center, Phase II Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Yong Zhang,MD · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of Tislelizumab combined with concurrent chemoradiotherapy in the treatment of cervical cancer patients with cervical mass \> 4cm and regional lymph node metastasis, paracervical invasion and regional lymph node metastasis, stage IIIA, stage IIIB, and stage IVA. To provide a clinical reference for finding a safe and effective individualized treatment plan to improve the survival prognosis of locally advanced cervical cancer patients.

Detailed description

This is a prospective, single-arm, single-center phase II clinical study. The objective is to evaluate the efficacy and safety of Tislelizumab combined with concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer. This study was independently completed by our center. Cervical cancer patients with cervical mass \> 4cm with regional lymph node metastasis, paracervical invasion with regional lymph node metastasis, stage IIIA, stage IIIB and stage IVA in FIGO stage 2018 were selected as subjects, and 30 patients were planned to be enrolled. External irradiation 45\~50Gy/25f+ Brachytherapy 28\~30Gy/4\~5f; Chemotherapy: DDP 40mg/m2/W, synchronous with radiotherapy, complete at least 4 cycles; Tislelizumab: 200mg/3W for 1 year or disease progression or intolerable toxicity, whichever occurs first.

Conditions

• Uterine Cervical Neoplasms

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab injection\[10ml:100mg\] will be used beginning with radiotherapy: 200mg/3W for 1 year or disease progression or intolerable toxicity, whichever occurs first.
DRUG	DDP synchronous with radiotherapy	DDP 40mg/m2/W, synchronous with radiotherapy, complete at least 4 cycles.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2022-10-20
• Last updated: 2023-11-24

Locations

1 site across 1 country: China