locally advanced cervical carcinoma
Conditions
Interventions
Case series:Apatinib + cisplatin + radiotherapy
Sponsors
Qinghai Red Cross Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old; 2. KPS = 70 points; 3. pathological diagnosis of cervical cancer and meet one of the following conditions: FIGO 2009 is scheduled for IB2, IIA2 to IVA; FIGO 2009 is divided into IB1 and IIA1 phases, and two or more imaging studies of pelvic and / or inguinal, abdominal aortic lymph node metastasis; 4. subjects received treatment of other damage has been restored (4 edition of the NCI-CTCAE classification is less than or equal to 1 grade), which received other cytotoxic drugs, radiotherapy or surgery over 4 weeks; the EGFR TKI class of molecular targeted drugs over 2 weeks;6 the main organs were normal: Blood routine examination, to comply with (without blood transfusion within 14 days): HB 90g/L); ANC 1.5*10^9/L); PLT 80*10^9/L). Biochemical tests should meet the following criteria: (BIL) 1.5 times the upper limit of normal value (ULN); ALT and AST*2.5*ULN; if there is liver metastasis, then ALT and AST 5*ULN; Serum Cr less than 1*ULN, creatinine clearance rate higher than 50ml/min (Cockcroft-Gault formula); 7. the expected survival time more than 3 months; 8. women of childbearing age had to have a pregnancy test (serum or urine) within 7 days before admission, and the results were negative, and were willing to use appropriate methods of contraception during the trial period and the last 8 weeks after the trial; 9. participants volunteered to participate in this study, signed informed consent, compliance, with follow-up.
Exclusion criteria
Exclusion criteria: 1. confirmed of apatinib and / or its accessories allergy; 2. with high blood pressure and the antihypertensive drug treatment can not be reduced to the normal range (>140 systolic blood pressure mmHg, diastolic blood pressure >90 mmHg), with I level above grade I coronary heart disease, arrhythmia (including QTc prolongation > 450 male MS, female MS > 470); 3. according to the NYHA standard, grade III to IV cardiac dysfunction, or heart color Doppler ultrasound examination of the left ventricular ejection fraction (LVEF) of the 50%; 4. urine protein positive patients; 5. have a variety of factors that affect oral drugs (such as swallowing, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 6. has a clear tendency in patients with gastrointestinal bleeding, including the following: local active ulcerative lesions, and fecal occult blood (+ +) can not be enrolled; 2 months melena, hematemesis history; 7. coagulation dysfunction (INR>1.5, APTT>1.5 ULN), with bleeding tendency; 8. There have been 8 genetic or acquired bleeding and thrombosis tendency (such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism etc.); 9. a long period of time that had not been cured, or had undergone major surgery or severe trauma, fractures, or ulcers within 30 days; 10. with abdominal gastrointestinal perforation or fistula, abdominal abscess; activity in patients with hepatitis B and hepatitis C; 11. imaging (CT or MRI) showed tumor lesions from large vessels less than 5 mm, or local vascular invasion lesions; 12. pregnant or lactating women; Patients with other malignancies within 13.5 years (including basal cell carcinoma and cervical carcinoma in situ); 14. with psychotropic drug abuse history and can't get rid of or mental disorder patients;15.Patients who participated in other clinical trials within 4 weeks; 16. received VEGFR inhibitors, such as Sola Fini and sunitinib; 17. according to the researcher's judgment, there is a serious harm to the patient's safety or affect the patient to complete the study of the accompanying disease; 18. the researchers found that those who were not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;QoL; | — |
Countries
China
Contacts
Public ContactKuan Zhang
Qinghai Red Cross Hospital
Outcome results
None listed