Concurrent chemoradiotherapy -immunotherapy followed by ICI maintenance was proved to improve the PFS by the Keynote-A18 in the LACC patients, and still more than 30% progressed. Neoadjuvant chemo-immunotherapy in LACC resulted in higher pCR rate. This prospective single arm study is to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy in LACC patients.
This prospective single arm study aims to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy in LACC patients. Patients will be given two cycles of TP regimen + Sintilimab, followed by concurrent chemoraiotherapy, and consolidative 6 cycles of Sintilimab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Neoadjuvant chemotherapy: The neoadjuvant regimen prior to radiotherapy consists of paclitaxel 135-175 mg/m², cisplatin 75 mg/m², and Sintilimab 200 mg, administered every 3 weeks for 2 cycles. Concurrent chemoradiotherapy: Radical dose to the pelvic concurrent with cisplatin. Consolidative immunotherapy: Following the completion of chemoradiotherapy, Sintilimab consolidation therapy will be administered based on treatment efficacy and the patient's physical condition, for a total of 6 cycles, starting 3-4 weeks after chemoradiotherapy.
Renji Hospital
Shanghai, Shanghai Municipality, China
Progression disease free survival
the time interval from the date of treatment to disease progression, local or distant recurrence
Time frame: 2 year
Adverse events
The number and incidence of adverse events and serious adverse events will be tabulated according to CTCAE 5.0
Time frame: one year from the start of immunotherapy
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