Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toripalimab+CCRT | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab | Drug | Toripalimab combined with CCRT |
| |
| CCRT |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year local control | absence of disease in the cervix (uterus), upper vagina or parametria on clinical examination, imaging, and biopsy | 2 year |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dan Ou | Contact | 8618801970632 | od12341@rjh.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Haoping Xu | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C000656314 | toripalimab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
|
| 2 year |
| 2-year overall survival | the time from the start of treatment until the date of death from any cause. | 2 year |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |