About this trial
To evaluate the efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in first-line treatment of stage IIIC2 cervical cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Diagnosed with any other cancer within the past 5 years;
Known allergy to any component of the drug;
Congenital or acquired immune deficiency (such as HIV infection);
The presence of any active, known or suspected autoimmune disease (such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.); Medical history of vitiligo; asthma which requires bronchodilators for medical intervention;
Trial design
Parallel
Treatments tested in this trial
tislelizumab
Drugstandard 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.
concurrent chemoradiotherapy
Other interventionstandard radiotherapy with concomitant cisplatin 40mg/m2 on day 1 once every week for 5 weeks.
Treatment groups
Trial outcomes
Primary outcomes
3-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).
side effect rate
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Secondary outcomes
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.
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.
Sponsors and contacts
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