Cervical Carcinom
Conditions
Interventions
group A:maintenance treatment group of capecitabine
group B:maintenance treatment group of apatinib combined with capecitabine
Sponsors
Guizhou Province Cancer Hospital Affiliated to Guizhou Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female patient is over 18 years old and under 70 years old; 2. ECOG PS score 0-1; 3. The estimated survival period is greater than or equal to 3 months; 4. Recurrent/metastatic cervical cancer patients whose disease control(CR, PR or SD) lasted six months after chemoradiotherapy had the pathological diagnosis of new local lesion or metastatic lesions of again, And Cervical cancer patients after initial treatment diagnosed by histology or cytology after chemoradiotherapy have efficacy evaluation of PR or SD and persistent measurable lesions. Patients with difficulty in obtaining pathological tissues, such as multiple metastases of deep organs, can be diagnosed in combination with the history of cervical cancer, laboratory examination and imaging examination (such as CT, MRI, PET/CT); 5. Efficacy evaluation and enrollment were at least 4 weeks after the end of the last radiotherapy or at least 6 weeks after the end of the last chemotherapy; 6. At least one measurable lesion (according to RECIST 1.1, the long diameter of tumor lesion is greater than 10mm and the short diameter of lymph node lesion is greater than 15mm in the CT scan); 7. Patients who have not received targeted drug therapy against angiogenesis; 8. The function of main organs was basically normal, and there was no obvious abnormality in hematopoietic function and liver and kidney function; 9. Women of child-bearing age must have taken reliable contraceptive measures, or have undergone pregnancy tests (serum or urine) within 7 days prior to enrollment, with negative results, and are willing to use appropriate contraceptives during the trial period and 8 weeks after the last administration of the experimental drugs; 10. Subjects voluntarily participated in this study, signed informed consent, good compliance, and coordinated follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with bilateral hydronephrosis that cannot be relieved by ureteral stents or percutaneous drainage; 2. Patients with active brain metastasis, carcinogenic meningitis and spinal cord compression (patients with brain metastasis with stable symptoms after treatment 21 days prior to enrollment can be enrolled in the group, but are confirmed to have no symptoms such as cerebral hemorrhage, high cranial pressure and cerebral edema by craniocerebral MRI, CT or venography evaluation); 3. Use two antihypertensive drugs to treat hypertension (systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg) that is still beyond control; 4. With severe cardiovascular disease: II magnitude myocardial ischemia or poor control of myocardial infarction, arrhythmia (including QTc 470 ms or higher); According to NYHA standard, III to IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) < 50%; 5. Abnormal coagulation function, or known hereditary or acquired bleeding tendency and thrombosis tendency; 6. A large amount of serosal cavity effusion (including pleural effusion, ascites, pericardial effusion, etc.); 7. Received major surgery or suffered severe traumatic injury, fracture or ulcer within 4 weeks of admission; 8. Factors that have a significant impact on oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction; 9. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months prior to admission; 10. The routine urine test indicates that the urine protein is greater than or equal to +, or the 24-hour urine protein content is greater than or equal to 1.0 g; 11. A person who has a history of psychotropic substance abuse and is unable to quit or has a mental disorder; 12. Patients who have suffered from other aggressive malignant tumors in the past 5 years or at the same time; 13. Women who are pregnant or lactating and are fertile are unwilling or unable to take effective contraceptive measures; 14. Participate in other clinical researchers 6 months before screening and during treatment; 15. Researchers determine other situations that may affect the conduct of clinical studies and the outcome of studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS (Progression-free survival);One-year survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR(Objective response rate);DCR(Disease control rate);OS(Overall survival); | — |
Countries
China
Contacts
Public ContactJiehui Li
Guizhou Medical University
Outcome results
None listed