Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zimberelimab, Platinum, radiotherapy.
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer (IB3, IIA2) Patients
Overview
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.
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 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.
Interventions
- Drug Zimberelimab
240mg, q3w，8 cycles - Drug Platinum
cisplatin 40mg/m2 for 5-6 cycles - Radiation radiotherapy
45-50Gy/1.8Gy/25-28f
Primary outcome measures
- changes in tumor-related biomarkers [Time frame: 3 years]
Secondary outcome measures (3)
- OS [Time frame: 5 years]
- DFS [Time frame: 2 years]
- AE [Time frame: 3 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06128460 · GLS-010-672