cervical carcinoma
Conditions
Sponsors
Shandong Institute of Cancer Prevention and Control
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old; 2. Cervical squamous cell carcinoma, adenosquamous cell carcinoma or adenocarcinoma confirmed by pathology at the time of initial treatment. It does not include the following rare pathological types of tumors: micrometallic adenocarcinoma, villous tubular adenocarcinoma, clear cell carcinoma or sarcoma, etc; 3. The initial treatment was synchronous radiotherapy and chemotherapy, and the chemotherapy drugs were paclitaxel combined with platinum; 4. Concurrent chemoradiotherapy in the treatment of IIIc-IVa phase cervical cancer with complete remission for the first time; 5. Diagnosis of cervical cancer: stage IIIc, IVa was confirmed by histology and imaging. It is impossible to obtain histology or cytologist for metastatic lymph nodes. Combined with history, laboratory examination and imaging examination (such as CT, MRI, PET / CT), it can provide clinical diagnosis; 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 7. Life expectancy greater than or equal to 3 months; 8 The damage caused by other treatment has recovered; 9. Subjects in the experimental group should not have received VEGF pathway inhibitors, such as bevacizumab, sorafenib and sunitinib; 10. Participants must have normal organ and marrow function as described below: (1) Blood routine examination standards should be met: Absolute neutrophil count >=1.5x10^9/L; Platelets>=80x10^9/L; (2) Biochemical examination shall meet the following standards: Total bilirubin = 1.5 ULN; ALT and AST=45ml/min; 11. Subjects joined the study voluntarily and signed the informed consent. They had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Those who have proved to be allergic to apatinib and / or its excipients; 2. Patients with hypertension who could not be reduced to the normal range by antihypertensive drugs (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 3. According to NYHA standard, grade III-IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) less than 50% indicated by color Doppler echocardiography; 4. The 24-hour urine protein content of patients with positive urine protein >=1.0 g was confirmed; 5. There are many factors that affect oral medication (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction); 6. Patients with a clear tendency of gastrointestinal bleeding, including the following conditions: local active ulcer focus, and stool occult blood (+ +) can not be included in the group}; patients with a history of black stool and hematemesis within 2 months; 7. Abnormal coagulation (INR > 1.5 APTT > 1.5 ULN), with bleeding tendency; 8. Long term wound or fracture, major surgical operation or severe traumatic injury, fracture or ulcer within 4 weeks; 9. Patients who have a history of psychoactive drug abuse and are unable to give up or have mental disorders; 10. According to the judgment of the researchers, there are patients with serious hazards to the safety of patients or accompanying diseases that affect the completion of the study; 11. Researchers do not think it is suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;safety;Quality of life; | — |
Countries
China
Contacts
Public ContactDapeng Li
Shandong Provincial Cancer Hospital
Outcome results
None listed