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Trial Title:
Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.
NCT ID:
NCT06128460
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Zimberelimab
Description:
240mg, q3w，8 cycles
Arm group label:
Concurrent themoradiotherapy Followed by Zimberelimab
Intervention type:
Drug
Intervention name:
Platinum
Description:
cisplatin 40mg/m2 for 5-6 cycles
Arm group label:
Concurrent themoradiotherapy Followed by Zimberelimab
Intervention type:
Radiation
Intervention name:
radiotherapy
Description:
45-50Gy/1.8Gy/25-28f
Arm group label:
Concurrent themoradiotherapy Followed by Zimberelimab
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
December 1, 2023
Completion date:
December 1, 2029
Lead sponsor:
Agency:
Obstetrics & Gynecology Hospital of Fudan University
Agency class:
Other
Source:
Obstetrics & Gynecology Hospital of Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06128460
