Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Concurrent themoradiotherapy Followed by Zimberelimab Radiotherapy: Intensity modulated conformal radiation therapy (IMRT) is used for external irradiation, and the pelvic target volume dose (PTV) is: 45-50 Gy/1.8Gy/25-28f; the stump margin is positive, and after the external irradiation is completed, Additional CT-guided three-dimensional conformal brachytherapy, HR-CTV: 24--30Gy/4-5f. Concurrent chemotherapy: performed during external radiotherapy. Starting from the first week of radiochemotherapy, cisplatin 40 mg/m2 was given. Chemotherapy is given every 7 days, up to 5-6 times; Zimberelimab injection: 240 mg/time, intravenous infusion, administered every 21 days, starting within four weeks after completing concurrent chemoradiotherapy, and maintained for 8 cycles |
Drug: Zimberelimab
240mg, q3w，8 cycles
Drug: Platinum
cisplatin 40mg/m2 for 5-6 cycles
Radiation: radiotherapy
45-50Gy/1.8Gy/25-28f
|
Outcome Measures
Primary Outcome Measures
- changes in tumor-related biomarkers [3 years]
changes of tumor- related biomarkers (T cell receptor library profile and peripheral blood ctDNA content analysis)
Secondary Outcome Measures
- OS [5 years]
Overall Survival
- DFS [3 years]
Disease Free Survival
- AE [3 years]
Adverse event
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma;
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According to FIGO2018 staging, patients with locally advanced cervical cancer (IB3, IIA2) with postoperative pathologic indications of high risk factors (lymph node metastasis, positive incisal margin, paracentral involvement) and/or lymphovascular space infiltration (LVSI positive);
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Laparoscopic resection of cervical cancer;
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Female patients: 18-70 years old;
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ECOG physical condition score: 0~1 point;
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Subjects have not received previous immunotherapy;
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Expected survival ≥6 months;
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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;
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For adequate organ function as defined in the protocol, test samples must be collected within 7 days prior to initiation of the study therapy
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Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.
Exclusion Criteria:
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Subjects have histological subtypes other than those permitted by inclusion criteria;
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Severe hypersensitivity to cepalizumab and/or any of its excipients (≥ grade 3);
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Participate in or have participated in other clinical trials within 4 weeks before enrollment;
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Have received or will receive inactivated vaccine within 30 days prior to the first study treatment;
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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;
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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;
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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);
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Have a history of (non-infectious) pneumonia requiring steroid treatment or have a current (non-infectious) pneumonia;
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An active infection requiring systematic treatment;
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Known history of HIV infection;
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A known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as detection of HCV RNA[qualitative]) infection;
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Known active tuberculosis (TB; Tuberculosis) medical history;
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Has received allogeneic tissue/solid organ transplantation;
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Suffering from central nervous system metastases such as brain metastases;
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Patients with uncontrolled chest and abdominal fluid;
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Patients with mobility disorders such as pathological fractures caused by tumor bone metastasis;
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Insufficient hematopoietic function of bone marrow;
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Abnormal liver;
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Abnormal kidney;
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Bleeding risk;
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Cardiovascular and cerebrovascular abnormalities.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Obstetrics & Gynecology Hospital of Fudan University
Investigators
- Principal Investigator: Keqin Hua, Doctor, Gynecology and obstetrics hospital of fudan university
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GLS-010-672