Actively Recruiting

Phase 2
Age: 18Years - 75Years
FEMALE
NCT05910177

Neoadjuvant Treatment of Neuroendocrine Cervix Carcinomar With Camrelizumab Combined With Etoposide and Cisplatin

Led by Fujian Cancer Hospital · Updated on 2024-03-06

30

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of karelizumab combined with etoposide and cisplatin in the neoadjuvant treatment of neuroendocrine cervix carcinoma.

CONDITIONS

Official Title

Neoadjuvant Treatment of Neuroendocrine Cervix Carcinomar With Camrelizumab Combined With Etoposide and Cisplatin

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 75 years
  • Confirmed cervical neuroendocrine carcinoma by histopathology or cytology with more than 60% neuroendocrine component if mixed type
  • FIGO stage I-II eligible for surgery by experienced gynecological oncologist
  • At least one measurable target lesion by RECIST 1.1 criteria (tumor lesion length  10mm, lymph node short diameter  15mm)
  • ECOG performance status of 0 or 1
  • Estimated postoperative survival time longer than 3 months
  • Normal organ function meeting blood and biochemical test criteria
  • No blood transfusion within 14 days before enrollment
  • Negative pregnancy test within 7 days before first treatment for women of childbearing age
  • Agreement to use contraception during treatment and 24 weeks after last medication
  • Voluntary informed consent and willingness to comply with study and follow-up
Not Eligible

You will not qualify if you...

  • Prior chemotherapy, radiation, targeted therapy, or immunotherapy
  • Contraindications to surgery or chemotherapy or poor physical or organ function preventing major abdominal surgery
  • Presence of distant metastasis
  • Active or history of autoimmune diseases except specified stable conditions
  • History of immune deficiency diseases or organ/bone marrow transplantation
  • Severe heart, lung, liver, kidney diseases, neurological or mental illness, jaundice, gastrointestinal obstruction, or severe infections
  • Pregnant or breastfeeding women
  • Coronary heart disease grade I or above, arrhythmias including prolonged QTc interval, or cardiac dysfunction
  • Abnormal coagulation function (INR > 1.5, APTT > 1.5 ULN)
  • Uncontrolled cardiovascular symptoms or diseases including heart failure NYHA grade II or above, unstable angina, recent myocardial infarction, or significant arrhythmias
  • History of interstitial lung disease or non-infectious pneumonia
  • Allergy to camrelizumab or any study medication components
  • Investigator judgment of unsuitability for inclusion

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

Fujian Cancer Hospital

Fuzhou, Fujian, China, 350014

Actively Recruiting

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Research Team

H

He Hai Xin

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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