cervical cancer
Conditions
Interventions
Group 1:Anlotinib combined with Gemcitabine
Group 2:Gemcitabine
Sponsors
The First People's Hospital of Yueyang
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged at least 18 years old; 2. Recurrent or metastatic advanced cervical cancer patients confirmed by pathology and imaging; 3. Recurrent or metastatic advanced cervical cancer patients who had received systemic first-line chemotherapy; 4. ECOG physical condition score: 0-1 points; 5. predicted survival period (> 3 months); 6. good function of main organs, no severe hypertension, diabetes and heart disease. Within the first 14 days of randomization, the relevant examination indicators meet the following requirements: (1) blood routine examination: hemoglobin (> 90 g/L) (no blood transfusion within 14 days); neutrophil count > 1.5 x 10^9/L; I I I platelet count (> 100 x 10^9/L); (2) biochemical examination: total bilirubin (< 1.5 x ULN) (upper limit of normal value); ALT or AST (< 2.5 x ULN); if there is any For liver metastasis, ALT or AST were less than 5 *ULN; Creatinine clearance rate was more than 60 ml/min (Cockcroft-Gault formula); (3) Doppler echocardiography evaluation: left ventricular ejection fraction (LVEF) was more than 50%; (4) blood glucose was controlled at fasting < 7.2 mmol/L, non-fasting < 10 mmol/L, and glycosylated hemoglobin < 7%. Sign the informed consent; Compliance is good, family members agree to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Participated in clinical trials of other drugs within four weeks, and used Apatinib, gemcitabine and bevacizumab in the past; 2. had multiple factors affecting oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction); 3. had a history of bleeding, and any bleeding events with a severe grade of 3 or more in CTCAE 4.0 occurred within the first four weeks of screening; 4. Central nervous system was known before screening. Patients with systemic metastasis or a history of central nervous system metastasis. For patients with suspected clinical central nervous system metastasis, CT or MRI examination must be performed within 28 days before randomization to exclude the central nervous system metastasis; 5. those with hypertension who cannot be well controlled by a single antihypertensive drug therapy (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); those with a history of unstable angina pectoris; those newly diagnosed as angina pectoris screened or screened within the first three months. Myocardial infarction occurred in the first six months; arrhythmia (including QTcF: men (> 450 ms) and women (> 470 ms) required long-term use of antiarrhythmic drugs and New York Heart Association grade (> II) cardiac insufficiency; Urinary Routine indicated that urinary protein (++) and confirmed 24-hour urinary protein quantification > 1.0 g; long-term union wounds or union incomplete fractures; imaging showed that tumors had already occurred. Invasion of important perivascular or judged by researchers that patients with tumors are highly likely to invade important blood vessels during treatment and cause fatal massive hemorrhage; Coagulation dysfunction, with a tendency to bleed (14 days before randomization must be satisfied: INR is within the normal range without anticoagulant); application of anticoagulants or vitamin K antagonists such as warfarin, heparin or their kind Patients treated with analogue therapy; on the premise that the international standardized ratio of prothrombin time (INR) is less than 1.5, low-dose warfarin (1 mg orally, once a day) or aspirin (less than 100 mg daily) is allowed for preventive purposes; _Arteriovenous thrombosis events such as cerebrovascular accident (including temporary ischemic attack) and deep thrombosis occurred within the first six months of screening. Venous thrombosis (venous thrombosis caused by intravenous catheterization due to pre-chemotherapy, except those who have been judged to be cured by researchers) and pulmonary embolism; Should be surgical sterilization, postmenopausal patients, or agree to use a medically approved contraceptive measure during the period of study treatment and within 6 months after the end of the study period; serum or urine pregnancy test must be negative within 7 days before the study group. And must be non-lactating period; 6. Thyroid dysfunction has existed in the past, even in the case of drug treatment, the thyroid function can not be maintained within the normal range; 7. those who have a history of psychotropic drug abuse and can not be withdrawn or have mental disorders; 8. pleural effusion or peritoneal effusion with clinical symptoms requiring clinical intervention; 9. history of immunodeficiency or other acquired or congenital immunodefic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;DCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;AEs; | — |
Countries
China
Contacts
Public ContactWen Fang
The First people's Hospital of Yueyang
Outcome results
None listed