Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.

NCT06128460 | Not Yet Recruiting Phase 2

• 1 other identifier: GLS-010-672
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• changes in tumor-related biomarkers

  changes of tumor- related biomarkers (T cell receptor library profile and peripheral blood ctDNA content analysis)

  3 years

Secondary Outcomes (3)

• OS

  5 years

• DFS

  2 years

• AE

  3 years

Study Arms (1)

Concurrent themoradiotherapy Followed by Zimberelimab

EXPERIMENTAL

1. 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. 2. 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; 3. 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; Drug: Platinum; Radiation: radiotherapy

Interventions

Zimberelimab DRUG

240mg, q3w，8 cycles

Concurrent themoradiotherapy Followed by Zimberelimab

Platinum DRUG

cisplatin 40mg/m2 for 5-6 cycles

Concurrent themoradiotherapy Followed by Zimberelimab

radiotherapy RADIATION

45-50Gy/1.8Gy/25-28f

Concurrent themoradiotherapy Followed by Zimberelimab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Obstetrics & Gynecology Hospital of Fudan University: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

zimberelimab; Platinum; Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Therapeutics

Study Officials

• Keqin Hua, Doctor

  Gynecology and obstetrics hospital of fudan university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junjun Qiu, Doctor

CONTACT

18017738139; qiujunjun1113@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gynecological Oncology

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share