Cervical squamous cell carcinoma
Conditions
Interventions
1:Apatinib monotherapy
Sponsors
Chongqing Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age 18 to 75 years old; 2) Patients volunteered to participate in this study, signed informed consent, good compliance, and follow-up; 3) The damage caused by the subject receiving other treatment has been restored (NCI CTCAE version 4.0 grade =1), ECOG PS score =3 points; 4) Expected survival is greater than 3 months; 5) pathological diagnosis of cervical squamous cell carcinoma; 6) evaluable lesions: Tumor lesion CT scan long diameter = 5mm, lymph node lesion CT scan short diameter = 10mm, scanning layer thickness is not more than 5mm (refer to RECIST 1.1) 7) First recurrence or persistent cervical squamous cell carcinoma (mainly residual tumor or progression at least 3 months after initial radiotherapy or concurrent chemoradiotherapy), and the patient is unable to undergo surgery or radiotherapy and chemotherapy; 8) The main organ function meets the following criteria within 7 days before treatment: A. Blood routine (without blood transfusion within 14 days): a. Hemoglobin (HB) = 90 g / L; b. Absolute neutrophil (ANC) ) = 1.0 × 109 / L; c. platelet (PLT) = 80 × 109 / L; B. biochemical examination criteria: a. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2 times the upper limit of normal (ULN), such as with liver metastasis, ALT and AST = 5 × ULN; b. total bilirubin (TBIL) = 1.5 × ULN; c. serum creatinine (Cr) = 1.5 × ULN or creatinine Clearance rate (CCr) = 60ml / min; d. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = normal value threshold (50%). 9) Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; the serum or urine pregnancy test is negative within 14 days prior to the study enrollment, and Must be a non-lactating patient.
Exclusion criteria
Exclusion criteria: 1) Patients who have been treated with apatinib mesylate or who have been confirmed to be allergic to apatinib and/or their excipients; 2) pathological types of non-squamous cancer; 3) have a variety of factors affecting oral medication (such as not being able to swallow, gastrointestinal resection, chronic diarrhea, etc.); 4) Other planned systemic anti-tumor treatments, including chemotherapy, immunotherapy, and signal transduction inhibitors, are planned within 4 weeks prior to grouping or during the study period. Radiotherapy was performed within 4 weeks prior to grouping; 5) Those who have achieved CR and PR after the current treatment and can tolerate continued treatment; 6) Imaging (CT or MRI) shows that the tumor lesion is = 5 mm from the large blood vessel, or there is a central tumor invading the local large blood vessel, or there is a significant pulmonary cavity or necrotizing tumor; 7) Those with symptoms of brain metastasis are not controlled; 8) Combine other malignant tumors; 9) those who suffer from high blood pressure and are still under poorly controlled by antihypertensive drugs (systolic blood pressure =150mmHg, diastolic blood pressure =100mmHg); 10) There are any serious and/or uncontrolled diseases, including: A. Active or uncontrolled serious infection (= CTC AE2 infection) B. Cirrhosis, decompensated liver disease, active hepatitis or chronic Hepatitis requires antiviral therapy; C. has a history of immunodeficiency, including HIV-positive or other acquired. Congenital immunodeficiency disease; D. Diabetic patients with poor glycemic control (fasting blood glucose (FBG) > 10mmol / L); E. myocardial infarction, severe arrhythmia and = 2 congestive heart failure (New York Heart Association (NYHA) Graded); F. Renal failure requires hemodialysis or peritoneal dialysis; 11) Urine routine indicates urinary protein = ++, or confirmed 24-hour urine protein = 1.0g; 12) Major surgical treatment or significant traumatic injury was received within 1 month prior to grouping; 13) Overactive/venous thrombosis events within 6 months, such as cerebrovascular accidents, myocardial infarction, deep vein thrombosis, and pulmonary embolism, especially in patients undergoing thrombolytic or anticoagulant therapy; 14) Within 4 weeks before grouping, there are bleeding such as melena and/or hematemesis and hemoptysis, and those with abnormal bleeding due to platelet or coagulation function; 15) Those with a history of unhealed wounds, ulcers, fracture history, cardiac arrest, and gastrointestinal perforation; 16) A confirmed ALK gene abnormality (gene fusion or mutation); 17) Those who received a potent CYP3A4 inhibitor within 7 days prior to randomization or who received a potent CYP3A4 inducer within 12 days prior to the study; 18) The use of chemotherapy drugs in previous medical history caused III~IV degree of myelosuppression: those with thrombocytopenia, within 3 months after the end of chemotherapy; 19) a patient who is pregnant or breastfeeding; 20) Patients who cannot understand the experimental content and cannot cooperate; 21) have received VEGFR inhibitors, such as sorafenib, sunitinib treatment; 22) refusal to sign the informed consent form; 23) According to the investigator's judgment, there are those accompanying diseases or other special circumstances that seriously endanger the safety of the patient or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactDongling Zou
Chongqing Cancer Hospital
Outcome results
None listed