Cervical Carcinoma
Conditions
Interventions
therapy group:sintilimab 200mg ivgtt q21d 2 years
Sponsors
Fujian Provincial Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Subjects voluntarily joined the study and signed informed consent; 2) Aged >18 years; 3) Patients must have persistent, recurrent or metastatic squamous cell carcinoma, adenosquamous carcinoma or cervical adenocarcinoma, and have a history of disease progression (the disease cannot be repaired by curative treatment); Note: The pathological report passed requires histological confirmation of the original primary tumor. 4) Not suitable for surgery or radiotherapy; 5) Patients must have received a regimen of systemic chemotherapy for the treatment of recurrent, metastatic cervical cancer, including: paclitaxel/platinum, paclitaxel/platinum/bevacizumab. Synchronous chemotherapy administered during radiotherapy is not a systemic chemotherapy regimen. Adjuvant chemotherapy given after completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted in systemic chemotherapy regimens (eg, paclitaxel and carboplatin for up to 4 cycles); Note: Patients who have received more than one treatment regimen are not eligible. 6) PD-1 expression is positive (>1%); 7) Patients must have measurable lesions as defined by the RECIST 1.1 standard; 8) ECOG body status score is 0 or 1; 9) Good organ function; A. Neutrophil count =1500/ul B. Platelets =100,000/ul C. Hemoglobin =10g/dl D. Serum creatinine = 1.5 times the upper limit of normal or creatinine clearance = 60ml / min E. Total bilirubin = 1.5 times the upper limit of normal value or direct bilirubin = 1.0 times the upper limit of normal value F.AST and ALT = 2.5 times the upper limit of normal value, liver transfer must be = 5 times the upper limit of normal value 10) Ability to comply with the program; 11) The toxic side effects of any previous chemotherapy have been restored to =CTCAE1 level or baseline level; 12) Expected survival time is greater than 3 months.
Exclusion criteria
Exclusion criteria: 1) The pathological type is neuroendocrine or small cell carcinoma; 2) Patients with a history of brain metastasis or signs of brain metastasis; 3) Receive anti-tumor monoclonal antibody or other research drugs within 4 weeks before enrollment; have received other anti-PD-1 antibody therapy or other treatment for PD-1/PD-L1; 4) The patient is using immunosuppressive or systemic hormonal therapy for immunosuppression purposes (dose greater than 10 mg/day of prednisone or other equivalent hormones) and is still in use 2 weeks prior to enrollment; 5) The patient has any active autoimmune disease or a history of autoimmune disease; 6) There are uncontrolled heart clinical symptoms or diseases; 7) Patients with congenital or acquired immune deficiency; 8) Receive chemotherapy, targeted therapy, radiotherapy within 2 weeks before enrollment; 9) Patients suspected of having other primary cancers; 10) Those who are known to be allergic to pharmaceutical ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DOR; | — |
Countries
China
Contacts
Public ContactXu Qin
Outcome results
None listed