Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06511726

Induction Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-02-14

29

Participants Needed

1

Research Sites

196 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a Phase II clinical study for patients with locally advanced cervical cancer, aimed at evaluating the efficacy, safety, and tolerability of Cadonilimab combined with chemotherapy as induction therapy.

CONDITIONS

Official Title

Induction Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with good compliance
  • Age 18 years or older
  • Histologically or pathologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) with measurable lesions
  • Initial diagnosis of stage IB3 to IVA cervical cancer (FIGO 2018 staging)
  • ECOG performance status of 0 to 2
  • Adequate main organ function within 7 days before treatment
Not Eligible

You will not qualify if you...

  • Other histological types of cervical cancer (e.g., neuroendocrine carcinoma, sarcoma)
  • Presence of distant metastases including groin lymph nodes and nodes above L1
  • Previous total hysterectomy (removal of uterus body and cervix); subtotal hysterectomy or cervical wedge resection allowed
  • Anatomical or tumor-related contraindications preventing brachytherapy
  • Other active malignant tumors within 2 years except certain cured local tumors
  • Clinically significant bilateral hydronephrosis not relieved by nephrostomy or stent
  • Prior treatment with immune checkpoint inhibitors or immune co-stimulatory factor therapies
  • Use of systemic glucocorticoids or immunosuppressants above specified doses within 2 weeks
  • Treatment with immunomodulatory drugs within 2 weeks
  • Active systemic infections requiring treatment
  • Severe infections within 4 weeks requiring hospitalization
  • Major surgery, open biopsy, or trauma within 4 weeks or planned major surgery during study
  • Live vaccines within 4 weeks
  • Active or history of autoimmune diseases except specified stable conditions
  • Certain cardiovascular diseases (NYHA class II or higher heart failure, severe arrhythmias, recent cerebrovascular events, LVEF below 50%)
  • Known immunodeficiency or positive HIV test
  • Active hepatitis B or C infections with specific criteria
  • Active or history of inflammatory bowel disease or diverticulitis
  • History of allogeneic organ or stem cell transplantation
  • History of severe allergic reactions to monoclonal antibodies
  • Pregnancy or breastfeeding
  • Any condition posing risk or interfering with study evaluation according to investigator judgment

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

Sun Yat-sen Memorial hosipital

Guangzhou, Guangdong, China, 510000

Actively Recruiting

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Research Team

L

Lin Ding

CONTACT

J

Jin Yang

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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Induction Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer | DecenTrialz