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.
(1)Age between 18 and 75; (2)Untreated patients with pathologically proven squamous carcinoma; (3)T3-4N1-2M0 cervical cancer; (4)Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1; (5)Adequate hematological, renal and hepatic functions: (6)Hemoglobin > 8.0 g/dl ; Neutrophils > 2000 cells/μl; Leukocytes > 4 × 109/L; Platelets > 100 × 109/L; Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL); Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL); Serum ALT/AST ≤ 2.5× UNL; Serum Total bilirubin ≤ 1.5× UNL; (7)Life expectancy > 6 months; (8)Eligible for concurrent chemoradiotherapy assessed by principle investigator; (9)No obvious active bleeding; (10)Written informed consent must be available before study registration.
(1)Recurrent or distant metastatic disease; (2)Prior malignancies (other than curable non-melanoma skin cancer) within 5 years; (3)Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants; (4)Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study; (5)Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study; (6)Previous organ transplantation or HIV patients; (7)Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component; (8)Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA> 2000 IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA> 10^3 copies/ml.
Single group
Neoadjuvant Chemotherapy (NACT)
DrugNeoadjuvant 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.
Progression disease free survival
the time interval from the date of treatment to disease progression, local or distant recurrence
Adverse events
The number and incidence of adverse events and serious adverse events will be tabulated according to CTCAE 5.0
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