Toripalimab Combined With Definitive CCRT for LACC Patients
- Conditions
- ChemoradiotherapyImmunotherapyCervical Cancer
- Interventions
- Radiation: CCRT
- Registration Number
- NCT06256224
- Lead Sponsor
- Ruijin Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Toripalimab+CCRT CCRT External beam radiotherapy (EBRT) of 45-50.4Gy was delivered using intensity modulated radiation therapy (IMRT) technique to the pelvic ± para-aortic fields in 25-28 fractions, 5 days a week and was followed by brachytherapy of 24-30Gy in 3-5 fractions, once a week. Concurrent chemotherapy of cisplatin, with a dose of 40 mg/m2 by intravenous infusion, was administered once a week for 5 weeks during EBRT. Toripalimab 240mg by intravenous infusion was administered every 3 weeks for 6 months and maintained upto 2 years for those whose lesions did not reach complete remission at six-month follow-up. CCRT CCRT EBRT of 45-50.4Gy was delivered using IMRT technique to the pelvic ± para-aortic fields in 25-28 fractions, 5 days a week and was followed by brachytherapy of 24-30Gy in 3-5 fractions, once a week. Concurrent chemotherapy of cisplatin, with a dose of 40 mg/m2 by intravenous infusion, was administered once a week for 5 weeks during EBRT. Toripalimab+CCRT Toripalimab External beam radiotherapy (EBRT) of 45-50.4Gy was delivered using intensity modulated radiation therapy (IMRT) technique to the pelvic ± para-aortic fields in 25-28 fractions, 5 days a week and was followed by brachytherapy of 24-30Gy in 3-5 fractions, once a week. Concurrent chemotherapy of cisplatin, with a dose of 40 mg/m2 by intravenous infusion, was administered once a week for 5 weeks during EBRT. Toripalimab 240mg by intravenous infusion was administered every 3 weeks for 6 months and maintained upto 2 years for those whose lesions did not reach complete remission at six-month follow-up.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Ruijin Hospital
🇨🇳Shanghai, Shanghai, China