Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.

Cervical Cancer Clinical Trial

Official title:

Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer (IB3, IIA2) Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06128460
• Other study ID #: GLS-010-672
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 1, 2023
• Est. completion date: December 1, 2029

Study information

• Verified date: November 2023
• Source: Obstetrics & Gynecology Hospital of Fudan University
• Contact: Junjun Qiu, Doctor
• Phone: 18017738139
• Email: qiujunjun1113[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 1, 2029
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Zimberelimab
240mg, q3w,8 cycles
• Platinum
cisplatin 40mg/m2 for 5-6 cycles

Radiation:
• radiotherapy
45-50Gy/1.8Gy/25-28f

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Obstetrics & Gynecology Hospital of Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in tumor-related biomarkers	changes of tumor- related biomarkers (T cell receptor library profile and peripheral blood ctDNA content analysis)	3 years
Secondary	OS	Overall Survival	5 years
Secondary	DFS	Disease Free Survival	2 years
Secondary	AE	Adverse event	3 years