Cervical Cancer, Chemoradiotherapy, Immunotherapy
Conditions
Brief 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.
Interventions
DRUGToripalimab
Toripalimab combined with CCRT
RADIATIONCCRT
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)
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year progression-free survival | 2 year | the date of the treatment to the date of disease progression or death from any cause in the absence of progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-year local control | 2 year | absence of disease in the cervix (uterus), upper vagina or parametria on clinical examination, imaging, and biopsy |
| 2-year local regional control | 2 year | absence of disease in the cervix (uterus), upper vagina or parametria and regional lymph nodes on clinical examination, imaging, and biopsy |
| 2-year overall survival | 2 year | the time from the start of treatment until the date of death from any cause. |
Countries
China
Contacts
Primary ContactDan Ou
Outcome results
None listed