Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.

• Status: Not yet recruiting
• Trial end date: 2029-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Obstetrics & Gynecology Hospital of Fudan University

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.