Clinical trial NCT06128460: Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.
Official title: Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer (IB3, IIA2) Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Cervical Cancer
Lead sponsor: Obstetrics & Gynecology Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: changes in tumor-related biomarkers
timeFrame: 3 years
Secondary outcomes:
measure: OS
timeFrame: 5 years
measure: DFS
timeFrame: 2 years
measure: AE
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Gynecology and obstetrics hospital of fudan university
name: Keqin Hua, Doctor
role: PRINCIPAL_INVESTIGATOR
References: