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Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer

NCT07104149 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-08-05

No results posted yet for this study

Summary

Main Purpose of this study is to determine the efficacy and safety of Cadonilimab combined with chemotherapy (cisplatin) for locally advanced cervical cancer.

This is an multicentre, single Arm, Phase 2 Trial study of Cadonilimab with Cisplatin in the treatment of locally advanced cervical cancer. 29 eligible patients will receive Cadonilimab（10mg/kg, iv., D1, q3w）with Cisplatin ( 75mg/ m2, iv., D2， q3w) for a total of 2-4 cycles before radical surgical treatment.

Conditions

  • Female, Age ≥ 18 Years Old
  • No Previous Systemic Treatment for the Current Disease, Including Surgery, Antitumor Radiochemotherapy/Immunotherapy
  • ECOG Score of 0-1
  • Histologically Confirmed Cervical Cancer, FIGO Stage IB3, IIA2, IIB, IIIC, and Assessed by the Researcher as Resectable Lesion
  • Sufficient Organ Function
  • The Result of the Urine or Serum Pregnancy Test for the Subject is Negative
  • Subjects Should Take Contraceptive Measures
  • Locally Advanced Cervical Cancer
  • Expected Survival Time >6 Months

Interventions

DRUG

Cadonilimab combined with cisplatin

Neoadjuvant chemotherapy plus cadonilimab for locally advanced cervical cancer

Sponsors & Collaborators

  • Second Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Henan Provincial People's Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Zhengzhou University

    lead OTHER

Principal Investigators

  • Xie Ya · The First Affiliated Hospital of Zhengzhou University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07104149 on ClinicalTrials.gov