cervical cancer
Conditions
Interventions
Group A:apatinib combined with iodine -125 seeds implantation
Group B:apatinib combined with iodine -125 seeds implantation
Group C:apatinib
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. Advanced cervical cancer patients confirmed by pathology and imaging; 3. Advanced cervical cancer patients who had received systemic chemotherapy or could not tolerate chemotherapy; 4. Mass diameter ( 3 months); Main organs function well, no serious hypertension, diabetes and heart disease; Sign 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; (2) had multiple factors affecting oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction); and (3) had a history of hemorrhage. Within the first four weeks of screening, any serious grade of hemorrhage occurred up to 3 degrees or more of CTCAE 4.0; and (4) Central nervous system transition was known before screening. A patient with a history of central nervous system metastasis. For patients suspected of clinical central nervous system metastasis, CT or MRI examination must be performed within 28 days before randomization to exclude central nervous system metastasis; (5) those with hypertension and unable to be well controlled by a single anti-hypertension drug therapy (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); those with a history of unstable angina pectoris; Myocardial infarction occurred in newly diagnosed angina pectoris within 3 months before selection or 6 months before screening; arrhythmia (including QTcF: males (> 450ms, females (> 470ms) 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 eggs. White Quantity > 1.0 g; Long-term union of wounds or incomplete healing of fractures; Imaging showed that the tumor had invaded the important perivascular or by the researchers judged that the patient's tumors were highly likely to invade the important blood vessels during treatment and cause fatal massive hemorrhage; Coagulation dysfunction, with a tendency to bleed (14 before randomization). Days must be met: INR is within the normal range without anticoagulants; patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; low doses of warfarin (1 mg mouth) are allowed for preventive purposes on the premise that the international standardized ratio of prothrombin time (INR) is less than 1.5 Take, once a day) or small dose of aspirin (dosage not exceeding 100 mg per day); _Arteriovenous thrombosis events occurred within 6 months before screening, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except for venous thrombosis caused by venous catheterization due to pre-chemotherapy, which has been cured by the investigators). Pulmonary embolism, etc.; (1) Surgical sterilization, postmenopausal patients, or consent to use a medically approved contraceptive measure within 6 months after the end of the study period and treatment period. Serum or urine pregnancy tests must be negative within 7 days before the study group, and must be non-lactating; (2) Thyroid dysfunction in the past, even in the case of drug treatment, the thyroid function can not be maintained within the normal range; (3) those who have a history of psychotropic drug abuse and can not be withdrawn or have mental disorders; (4) pleural effusion or peritoneal effusion with clinical symptoms requiring clinical intervention; and (5) a history of immunodeficiency. Or suffer from other acquired, congenital immunodeficiency disorders, or history of organ transplantation. According to the judgement of researchers, there are concomitant diseases that seriously endanger patients'safety or affect patients' completion of research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;DCR;AEs; | — |
Countries
China
Contacts
Public ContactXie Wangti
The First people's Hospital of Yueyang
Outcome results
None listed