Cervical Cancer
Conditions
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 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
DRUGZimberelimab
240mg, q3w，8 cycles
DRUGPlatinum
cisplatin 40mg/m2 for 5-6 cycles
RADIATIONradiotherapy
45-50Gy/1.8Gy/25-28f
Sponsors
Obstetrics & Gynecology Hospital of Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in tumor-related biomarkers | 3 years | changes of tumor- related biomarkers (T cell receptor library profile and peripheral blood ctDNA content analysis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 5 years | Overall Survival |
| DFS | 2 years | Disease Free Survival |
| AE | 3 years | Adverse event |
Contacts
Primary ContactJunjun Qiu, Doctor
Outcome results
None listed