Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer

Phase 2

Recruiting

• Conditions: Cervical Cancer
• Interventions: Drug: tislelizumab; Other: concurrent chemoradiotherapy

• Registration Number: NCT05511623
• Lead Sponsor: First Affiliated Hospital of Guangxi Medical University

Brief Summary

To evaluate the efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in first-line treatment of stage IIIC2 cervical cancer.

Detailed Description

This is a multicenter, prospective, and randomized phase II clinical trial. Patients assigned to experimental group will receive standard radiotherapy with concomitant cisplatin 40mg/m2 once every week for 5 weeks, combined with tislelizumab (200 mg, day 1) once every 3 weeks until disease progression or intolerable toxicity occurs or one year. Patients assigned to control group will undergo standard radiotherapy with concomitant cisplatin 40mg/m2 once every week for 5 weeks. Compare the efficacy and toxicity of the two regimens in patients with stage IIIC2 cervical cancer.

Study Timeline

• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-23
• Study Start: 2022-09-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11
• Primary Completion: 2024-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tislelizumab	tislelizumab	The external radiation is administered at 45-50Gy/25f and brachytherapy is performed sequentially at 6Gy/time to a total doses of 30 Gy. The concomitant chemotherapy regimen is cisplatin 40mg/m2 on day 1 once every week for 5 weeks. In addition, patients also receive tislelizumab (200 mg, day 1) once every 3 weeks until disease progression or intolerable toxicity occurs or one year.
concurrent chemoradiotherapy	concurrent chemoradiotherapy	The external radiation is administered at 45-50Gy/25f and brachytherapy is performed sequentially at 6Gy/time to a total doses of 30 Gy. The concomitant chemotherapy regimen is cisplatin 40mg/m2 on day 1 once every week for 5 weeks.

Primary Outcome Measures

Name	Time	Method
side effect rate	up to 3 years	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
3-year progress free survival rate	up to 3 years	Progression-free survival (PFS) is defined as the time between entry into the study and progression of the tumor (in any respect) or death (from any cause).

Secondary Outcome Measures

Name	Time	Method
Objective response rate(ORR)	3 months, after chemoradiotherapy	ORR is defined as the proportion of patients with CR or PR, assessed by RECIST v1.1 per independent central radiologic review.
3-year overall survival rate	up to 3 years	overall survival rate（OS）is calculated from the date of entry into the study to the date of death or the last follow-up visit.

Trial Locations

Locations (1)

First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China