Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
FEMALE
NCT06093438

Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-03-11

20

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To explore the efficacy of incorporating neoadjuvant immunotherapy into neoadjuvant chemotherapy in locally advanced cervical cancer patients with high risk of recurrence.

CONDITIONS

Official Title

Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Untreated locally advanced cervical cancer patients with clear pathological diagnosis
  • 2019 FIGO stage IIIB-IVA; for stage IIIC, metastatic lymph nodes must be at least 1.5 cm in short diameter
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy greater than 6 months
  • Able to tolerate concurrent chemoradiotherapy as assessed by researchers
  • No obvious active bleeding
  • Adequate hematological, renal, and hepatic functions
  • No other malignancies present
  • Female subjects of childbearing potential must have a negative pregnancy test and agree to use reliable contraception during the trial
  • Voluntarily signed informed consent
Not Eligible

You will not qualify if you...

  • Having other malignancies besides cervical cancer
  • Presence of metastatic or recurrent disease
  • Previous treatment for cervical cancer before enrollment
  • Severe chronic diseases such as diabetes or hypertension, or acute infections
  • Impaired blood, kidney, or liver function including:
    • Hemoglobin below 9.0 g/dl
    • Neutrophils below 2000 cells/µl or leukocytes below 4 x 10^9/L
    • Platelets above 100 x 10^9/L
    • Serum ALT/AST more than 2.5 times the upper normal limit
    • Serum total bilirubin above 1.5 times the upper normal limit
    • Serum urea nitrogen more than 1.5 times the upper normal limit
    • Serum creatinine more than 1.5 times the upper normal limit
  • Heart conditions like arrhythmia, myocardial ischemia, severe AV block, heart failure, or severe valve disease
  • Uncontrolled mental illnesses
  • Pregnant or breastfeeding women
  • Currently participating in other clinical trials
  • Considered unsuitable for enrollment by the principal investigator

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

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China, 300060

Actively Recruiting

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Research Team

Y

Yuanjie Cao

CONTACT

C

Chen Li

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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