To evaluate the efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in first-line treatment of stage IIIC2 cervical cancer.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
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.
standard radiotherapy with concomitant cisplatin 40mg/m2 on day 1 once every week for 5 weeks.
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITING3-year progress free survival rate
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).
Time frame: up to 3 years
side effect rate
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: up to 3 years
Objective response rate(ORR)
ORR is defined as the proportion of patients with CR or PR, assessed by RECIST v1.1 per independent central radiologic review.
Time frame: 3 months, after chemoradiotherapy
3-year overall survival rate
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.
Time frame: up to 3 years
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