adjuvant chemoradiotherapy followed by zimberelimab for locally advanced cervical cancer.

Conditions: Cervical Cancer

Summary: locally advanced cervical cancer (stage ib3, iia2) patients with postoperative risk factors need better treatment. we initiated a clinical study to explore the effectiveness of adjuvant chemoradiotherapy followed by zimberelimab for these patients.

for cervical cancer, although clinical research on pd-1 monoclonal antibodies was launched relatively late, the research results so far show that pd-1 monoclonal antibodies combined with chemotherapy have a high clinical effectiveness and a relatively high efficacy in the treatment of advanced/recurrent cervical cancer. good security. however, there is currently a lack of clinical evidence for the use of pd-1 monoclonal antibodies combined with chemoradiotherapy in the treatment of high-risk patients after cervical cancer surgery. therefore, this study intends to explore the clinical efficacy of postoperative adjuvant radiochemotherapy followed by pd-1 monoclonal antibody in the treatment of high-risk patients with locally advanced (ib3, iia2) cervical cancer after surgery, and provide a new solution for clinical treatment.

Eligibility criteria:
inclusion criteria: * histologically confirmed cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma; * according to figo2018 staging, patients with locally advanced cervical cancer (ib3, iia2) who require concurrent radiotherapy and chemotherapy; * patients with radical surgery for cervical cancer; * female patients: 18-70 years old; * ecog physical condition score: 0\~1 point; * subjects have not received previous immunotherapy; * expected survival ≥6 months; * women of reproductive age should agree to use contraceptives (such as iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; * for adequate organ function as defined in the protocol, test samples must be collected within 7 days prior to initiation of the study therapy * subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up. exclusion criteria: * subjects have histological subtypes other than those permitted by inclusion criteria; * severe hypersensitivity to cepalizumab and/or any of its excipients (≥ grade 3); * participate in or have participated in other clinical trials within 4 weeks before enrollment; * have received or will receive inactivated vaccine within 30 days prior to the first study treatment; * received a combination of systemic immune stimulants, colony-stimulating factors, interferon, interleukin, and vaccine within 6 weeks or 5 half-lives (if shorter) prior to initial administration; * have been diagnosed with an immune deficiency or are receiving chronic systemic steroid therapy (doses greater than 10mg daily equivalent of prednisone) or any other form of immunosuppressive therapy within 7 days prior to the first dose; * have an active autoimmune disease in the past 2 years that requires systemic treatment (such as the use of disease-modulating drugs, corticosteroids, or immunosuppressive drugs); * have a history of (non-infectious) pneumonia requiring steroid treatment or have a current (non-infectious) pneumonia; * an active infection requiring systematic treatment; * known history of hiv infection; * a known history of hepatitis b (defined as hbsag reactive) or known active hepatitis c virus (defined as detection of hcv rna\[qualitative\]) infection; * known active tuberculosis (tb; tuberculosis) medical history; * has received allogeneic tissue/solid organ transplantation; * suffering from central nervous system metastases such as brain metastases; * patients with uncontrolled chest and abdominal fluid; * patients with mobility disorders such as pathological fractures caused by tumor bone metastasis; * insufficient hematopoietic function of bone marrow; * abnormal liver; * abnormal kidney; * bleeding risk; * cardiovascular and cerebrovascular abnormalities.