Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06055738

Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of LACC

Led by Tang-Du Hospital · Updated on 2023-09-28

20

Participants Needed

1

Research Sites

220 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective, single arm, phase II clinical study to evaluate the efficacy and safety of Zimberelimab combined with albumin-bound paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer.

CONDITIONS

Official Title

Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of LACC

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary participation in clinical research.
  • Female, 18 years old or older.
  • Histologically or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.
  • Previously untreated locally advanced cervical cancer (2018 FIGO stage IB3, IIA2).
  • At least one measurable lesion suitable for target lesion evaluation according to RECIST v1.1.
  • Normal major organ functions within 14 days before first treatment.
  • ECOG performance status score of 0 or 1.
  • Agreement to provide sufficient tumor tissue samples for PD-L1 expression testing.
  • If positive for hepatitis B surface antigen or core antibody, HBV DNA must be less than 10^4 copies/ml or 2000 IU/mL, or have received antiviral therapy for at least 4 weeks and willing to continue during the study.
  • Agree to use contraception during treatment and for at least 6 months after the last dose if of childbearing potential.
Not Eligible

You will not qualify if you...

  • Active autoimmune disease or history of autoimmune disease.
  • Previous allogeneic hematopoietic stem cell or organ transplantation (except corneal).
  • Use of immunosuppressive drugs within 14 days before treatment, except for nasal sprays, inhaled corticosteroids, or physiological doses of systemic steroids.
  • Previous treatment with PD-1, PD-L1, PD-L2, CD137, or CTLA-4 antibodies.
  • Arterial or venous thromboembolic events within 6 months prior, except stable thrombus after anticoagulant therapy.
  • History of gastrointestinal or genital fistulas or perforations unless treated and recovered.
  • Symptomatic congestive heart failure (NYHA class II-IV) or poorly controlled arrhythmias.
  • Active pulmonary tuberculosis under treatment.
  • Interstitial lung disease.
  • Severe or poorly controlled infections within 3 weeks before treatment.
  • Central nervous system metastases or leptomeningeal disease.
  • HIV or known syphilis infection.
  • Received live vaccine within 4 weeks before study or plans to receive during study.
  • Known allergy to study drugs.
  • Pregnant or breastfeeding women.
  • Other conditions deemed inappropriate by the 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

Hongxi Zhao

Xi'an, Shaanxi, China, 710000

Actively Recruiting

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Research Team

H

Hongxi Zhao, PhD

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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Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of LACC | DecenTrialz