Status:
NOT_YET_RECRUITING
Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.
Lead Sponsor:
Obstetrics & Gynecology Hospital of Fudan University
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief 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 chemoradiother...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06128460
Start Date
December 1 2023
End Date
December 1 2029
Last Update
November 30 2023
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