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NCT Number: NCT06256224

Toripalimab Combined With Definitive CCRT for LACC Patients

Cervical cancer constitutes a significant health burden for women globally. While most patients with early-stage disease can be cured with radical surgery or chemoradiotherapy, patients with high-risk locally advanced disease or with recurrent/metastatic disease have a poor prognosis with standard treatments. Immunotherapies are a rational treatment for this HPV-driven cancer that commonly expresses programmed cell death ligand-1. Toripalimab, a humanized immunoglobulin G4 monoclonal antibody against PD-1, showed promising anti-tumor efficacy in multiple solid tumors. This randomised study is evaluating toripalimab combined with CCRT versus CCRT alone for treatment-naïve LACC.

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Key information

Conditions

Cervical Cancer Chemoradiotherapy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Immunotherapy Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • more than 18 years old females
  • had newly diagnosed and previously untreated locally advanced squamous cell carcinoma of the uterine cervix
  • FIGO 2018 stage IB3 to IVA with no evidence of distant metastasis
  • ECOG PS 0-1 without major organ failure
  • signed informed consent voluntarily

Exclusion criteria

  • previously suffered from immunodeficiency disorders
  • had any condition that researchers believed to be associated with increased risk of treatment
  • Previously received or currently receiving other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1

Treatment and study plan

Toripalimab

Drug

Toripalimab combined with CCRT

CCRT

Radiation

CCRT includes cisplatin (40 mg/m2, once a week for 5 weeks), radiotherapy (45-50.4Gy/25-28Fx, 5 fractions a week, followed by brachytherapy 24-30Gy/3-5Fx)

Primary outcomes

  1. 2-year progression-free survival

    Time frame: 2 year

    the date of the treatment to the date of disease progression or death from any cause in the absence of progression

Secondary outcomes

  1. 2-year local control

    Time frame: 2 year

    absence of disease in the cervix (uterus), upper vagina or parametria on clinical examination, imaging, and biopsy

  2. 2-year local regional control

    Time frame: 2 year

    absence of disease in the cervix (uterus), upper vagina or parametria and regional lymph nodes on clinical examination, imaging, and biopsy

  3. 2-year overall survival

    Time frame: 2 year

    the time from the start of treatment until the date of death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Dan Ou

CONTACT

[email protected]

8618801970632

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Toripalimab Combined With Definitive Chemoradiotherapy for Locally Advanced Cervical Squamous Cell Carcinoma Patients

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 13, 2024
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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