Cervical Cancer
Conditions
Interventions
Experimental group:Pienpilimumab combined with anlotinib for systemic therapy
Sponsors
Affiliated Hospital of Guizhou Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily joined the study and signed the informed consent; 2. Aged 18-75 years; 3. Patients must have pathologically confirmed recurrent or metastatic squamous cell carcinoma, adenosquamous carcinoma or cervical adenocarcinoma; 4. The patient must have received at least one standard platinum-containing systemic chemotherapy regimen for the treatment of recurrent or metastatic cervical cancer; or cannot tolerate chemotherapy; 5. Not suitable for local treatment (no surgery or radiotherapy); 6. Patients must have measurable lesions defined by RECIST1.1 criteria; 7. ECOG physical status score of 0 or 1; 8. The expected survival time is greater than 3 months; 9. Good organ function: neutrophil count >=1500/ul, platelet >=80,000/ul, hemoglobin >=9g/dl, serum creatinine =60ml/min, total bilirubin <= 1.5 times the upper limit of normal or direct bilirubin <= 1.0 times the upper limit of normal, AST and ALT <= 2.5 times the upper limit of normal, and liver metastases must be <= 5 times the upper limit of normal.
Exclusion criteria
Exclusion criteria: 1. There have been or are currently suffering from other malignant tumors within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor; 2. Patients with a history of brain metastases or signs of brain metastases; 3. Received anti-tumor monoclonal antibody or other investigational drug therapy within 4 weeks before enrollment; received other anti-PD-1 antibody therapy or other PD-1/PD-L1 therapy in the past; 4. Anlotinib or other small molecule TKI vascular inhibitors (such as apatinib, etc.) have been used in the past; 5. Those who are known to be allergic to drug ingredients; 6. Those with multiple factors that affect oral drugs (such as inability to swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 7. The patient is using immunosuppressant or systemic hormone therapy to achieve the purpose of immunosuppression (dose greater than 10mg/day prednisone or other equivalent hormones), and is still using it within 2 weeks before enrollment; 8. The patient has any active autoimmune disease or has a history of autoimmune disease; 9. Have uncontrolled clinical symptoms or diseases of the heart; 10. Receive chemotherapy, targeted therapy, and radiotherapy within 2 weeks before enrollment; 11. Those who have a history of gastrointestinal perforation or have undergone major surgery within 4 weeks before enrollment; 12. Arterial/venous thrombotic events, such as cardiovascular-cerebrovascular accident (including temporary ischemic attack), occurred within 6 months before enrollment, deep venous thrombosis (except for venous thrombosis caused by venous catheterization due to previous chemotherapy, which has been cured by the investigator's judgment) and pulmonary embolism; 13. Those with active bleeding or bleeding tendency; 14. Hypertension that is not controlled by drugs; 15. Urine routine indicates urine protein 2+ or more or 24-hour urine protein > 150mg/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence and metastasis; | — |
Countries
China
Contacts
Public ContactLi Fenghu
Affiliated Hospital of Guizhou Medical University
Outcome results
None listed