Actively Recruiting

Phase 2
Age: 18Years - 75Years
FEMALE
NCT07104149

Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer

Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2025-08-05

29

Participants Needed

1

Research Sites

120 weeks

Total Duration

On this page

Sponsors

T

The First Affiliated Hospital of Zhengzhou University

Lead Sponsor

S

Second Affiliated Hospital of Zhengzhou University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 years or older
  • Histologically confirmed cervical cancer, FIGO stage IB3, IIA2, IIB, or IIIC, with lesion assessed as resectable
  • No previous systemic treatment for the current disease, including surgery, chemoradiotherapy, or immunotherapy
  • Willingness to undergo radical surgical treatment without contraindications
  • ECOG performance status of 0 or 1
  • Expected survival time greater than 6 months
  • Adequate organ function with neutrophil count ≥1.5x10^9/L, platelets ≥100x10^9/L, hemoglobin >9 g/dL, total bilirubin ≤1.5 times upper limit of normal, AST and ALT ≤2.5 times upper limit of normal, serum creatinine ≤1.5 times upper limit of normal, creatinine clearance ≥60 ml/min, normal thyroid function, and normal myocardial enzymes
  • Negative pregnancy test and use of contraceptive measures
Not Eligible

You will not qualify if you...

  • Diagnosis of other malignancies within 5 years prior to first dose (except certain skin cancers and carcinoma in situ)
  • Participation in other interventional clinical trials or receipt of investigational drugs/devices within 4 weeks prior to first dose
  • Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or drugs targeting T-cell receptors
  • Systemic treatment with antitumor Chinese herbal medicines or immunomodulatory agents within 2 weeks prior to first dose
  • Active autoimmune disease requiring systemic treatment within 2 years prior to first dose
  • Systemic glucocorticoid or immunosuppressive therapy within 7 days prior to first dose
  • History of allogeneic organ or hematopoietic stem cell transplantation (excluding corneal transplants)
  • Known hypersensitivity to study drugs
  • Multiple factors affecting cisplatin use, such as platinum allergy
  • Incomplete recovery from prior treatment-related toxicity greater than Grade 1 (excluding fatigue or alopecia)
  • Known HIV infection
  • Untreated active hepatitis B or active hepatitis C infection
  • Live vaccine administration within 30 days prior to first dose
  • Pregnant or breastfeeding women
  • Severe or uncontrolled systemic diseases, including significant heart rhythm abnormalities, unstable angina, heart failure NYHA class II or higher, recent arterial thromboembolism or stroke, poorly controlled hypertension, recent pneumonitis or active lung disease
  • Active tuberculosis or uncontrolled infections
  • Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction
  • Liver diseases such as cirrhosis or active hepatitis
  • Poorly controlled diabetes with fasting glucose above 10 mmol/L
  • Significant proteinuria
  • Psychiatric disorders impairing compliance
  • Any condition judged by investigator to interfere with study participation or outcomes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450000

Actively Recruiting

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Research Team

X

Xie Ya

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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