Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT06128460
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06128460
Study Brief:
Protocol Section:
NCT06128460