Toripalimab Combined With Definitive CCRT for LACC Patients

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06256224
• Other study ID #: 2024(022)
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2024
• Source: Ruijin Hospital
• Contact: Dan Ou
• Phone: 8618801970632
• Email: od12341[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Chemoradiotherapy
• Immunotherapy
• Uterine Cervical Neoplasms

Intervention

Drug:
• Toripalimab
Toripalimab combined with CCRT

Radiation:
• CCRT
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)

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year progression-free survival	the date of the treatment to the date of disease progression or death from any cause in the absence of progression	2 year
Secondary	2-year local control	absence of disease in the cervix (uterus), upper vagina or parametria on clinical examination, imaging, and biopsy	2 year
Secondary	2-year local regional control	absence of disease in the cervix (uterus), upper vagina or parametria and regional lymph nodes on clinical examination, imaging, and biopsy	2 year
Secondary	2-year overall survival	the time from the start of treatment until the date of death from any cause.	2 year