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Not yet recruitingNCT06128460Updated Nov 30, 2023

Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.

A Phase 2 interventional study of Zimberelimab and Platinum in Cervical Cancer, sponsored by Obstetrics & Gynecology Hospital of Fudan University. Not yet recruiting. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-30.

Sponsored by Obstetrics & Gynecology Hospital of Fudan University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Cervical Cancer
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 24 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Obstetrics & Gynecology Hospital of Fudan University is the lead sponsor of 23 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Concurrent themoradiotherapy Followed by Zimberelimab

    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

  • DrugZimberelimab

    240mg, q3w,8 cycles

  • DrugPlatinum

    cisplatin 40mg/m2 for 5-6 cycles

  • Radiationradiotherapy

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

06

What researchers measure

Primary outcomes

  1. changes in tumor-related biomarkers

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

    Time frame: 3 years

Secondary outcomes

  1. OS

    Overall Survival

    Time frame: 5 years

  2. DFS

    Disease Free Survival

    Time frame: 2 years

  3. AE

    Adverse event

    Time frame: 3 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06128460
Lead sponsor
Obstetrics & Gynecology Hospital of Fudan University
Responsible party
Keqin Hua (Director of Gynecological Oncology, Obstetrics & Gynecology Hospital of Fudan University) — Principal investigator
First posted
Nov 13, 2023
Start date
Dec 1, 2023 (estimated)
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 1, 2029 (estimated)
Last update
Nov 30, 2023

Study contacts

Junjun Qiu, Doctor
Contact
qiujunjun1113@163.com
18017738139
Keqin Hua, Doctor
principal investigator · Gynecology and obstetrics hospital of fudan university

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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