Efficacy and Safety of Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer
Overview
- Phase
- Phase 2
- Intervention
- tislelizumab
- Conditions
- Cervical Cancer
- Sponsor
- First Affiliated Hospital of Guangxi Medical University
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- side effect rate
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: tislelizumab
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.
Intervention: concurrent chemoradiotherapy
Outcomes
Primary Outcomes
side effect rate
Time Frame: up to 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
3-year progress free survival rate
Time Frame: 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 Outcomes
- Objective response rate(ORR)(3 months, after chemoradiotherapy)
- 3-year overall survival rate(up to 3 years)