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Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.

ConditionCervical Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorObstetrics & Gynecology Hospital of Fudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Zimberelimab

    Drug

    240mg, q3w，8 cycles

  • Platinum

    Drug

    cisplatin 40mg/m2 for 5-6 cycles

  • radiotherapy

    Radiation

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

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Concurrent themoradiotherapy Followed by ZimberelimabExperimental treatment 3 interventions

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Obstetrics & Gynecology Hospital of Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: