Cervical Carcinoma
Conditions
Interventions
experimental group :sintilimab 200mg ivgtt q21d
anlotinib 10mg before breakfast oral qd for 14 days, 7 days of withdrawal, 21 days for a course of treatment
treatment for 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 = 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) Previous use of anlotinib; 5) 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; 6) The patient has any active autoimmune disease or a history of autoimmune disease; 7) There are uncontrolled heart clinical symptoms or diseases; 8) Patients with congenital or acquired immune deficiency; 9) Receive chemotherapy, targeted therapy, radiotherapy within 2 weeks before enrollment; 10) A history of gastrointestinal perforation or major surgery within 4 weeks before enrollment; 11) Overactive/venous thrombosis occurred within 6 months prior to enrollment, such as cardiovascular-cerebral vascular (including transient ischemic attack),deep vein thrombosis (except for patients who have recovered from venous catheterization due to previous chemotherapy)and pulmonary embolism; 12) Those with active bleeding or bleeding tendency; 13) Presence of a drug uncontrolled hypertension; 14) Urine routine indicates more than urinary protein 2+; 15) Correct QT interval > 470msec; if the patient has a prolonged QT interval, but the investigator's study evaluates that the prolongation is due to a cardiac pacemaker (and no other abnormalities in the heart), it is necessary to discuss with the sponsor's researcher to determine if the patient is Suitable for group study; 16) Patients suspected of having other primary cancers; 17) Those who are known to be allergic to pharmaceutical ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DOR;DCR; | — |
Countries
China
Contacts
Public ContactXu Qin
Fujian Provincial Cancer Hospital
Outcome results
None listed