Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: Zimberelimab; Drug: Platinum; Radiation: radiotherapy

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Junjun Qiu, Doctor; Phone Number: 18017738139; Email: qiujunjun1113@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in tumor-related biomarkers	changes of tumor- related biomarkers (T cell receptor library profile and peripheral blood ctDNA content analysis)	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFS	Disease Free Survival	2 years
OS	Overall Survival	5 years
AE	Adverse event	3 years

Collaborators and Investigators

• Sponsor: Obstetrics & Gynecology Hospital of Fudan University
• Investigators: Principal Investigator: Keqin Hua, Doctor, Gynecology and obstetrics hospital of fudan university

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms
• Other Study ID Numbers: GLS-010-672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No