Ovarian cancer
Conditions
Interventions
Case series:LBP
Sponsors
Chongqing Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. women aged 18-80 years old; 2. histopathology is diagnosed as primary epithelial ovarian cancer, fallopian tube carcinoma and peritoneal cancer. Pathological grading includes low differentiation, moderate differentiation and high differentiation; 3. surgical staging: stage I-IV, according to FIGO 2014 staging standard; 4. After satisfactory tumor cell reduction (residual tumor diameter less than 1.0cm), and regular and full dose chemotherapy to complete clinical complete remission, the evidence of recurrent tumor recurrence for more than 6 months (>6 months): 1) CA125 increase; 2) thoracoascites; 3) physical examination; 4) imaging examination of mass; 5) unexplained intestinal obstruction; 5. there must be at least one measurable lesion (RECIST v1.1); 6. No recurrence of any palliative chemotherapy or molecular targeted drug therapy for ovarian cancer (including monoclonal antibodies or small molecule tyrosine kinase inhibitors); 7. ECOG PS:0 or 1; 8. more than expected survival time in March; 9. The laboratory examination accords with the following standards: Bone marrow function: the absolute count of blood neutrophils (ANC) is more than 2 x 10^9/L, platelets (PLT) is more than 100 x 10^9/L, hemoglobin (HB) is more than 90g/L; Liver function: serum total bilirubin (TBIL), direct bilirubin (DBIL) below the upper limit of normal value (ULN) x 1.5; alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than ULN * 2.5 (in the absence of liver metastases); or less than ULN x 5 (with liver metastasis); Renal function: creatinine (Cr) is less than ULN, endogenous creatinine clearance rate (Ccr) is more than 55 ml/min (Cockcroft-Gault formula is applied, see Appendix 1). coagulation function: prothrombin time (PT) and international normalized ratio (INR) = ULN * 1.5; 10. for women who have fertility, they agree to abstinence or contraception within 6 months of treatment and last time; 11. The patient voluntarily signed and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have been allergic to platinum drugs in the past; 2. It is known to be allergic to any component in paclitaxel; 3. with severe cardiovascular disease, including hypertension (BP > 160/95mmHg), unstable angina pectoris, myocardial infarction history in the past June, >NYHA II of congestive heart failure, serious arrhythmia and pericardial effusion in the past June. 4. with severe ADH abnormal secretory syndrome and poor control of diabetes: more than 40 units of insulin should be administered continuously every day, or more than 40 units of insulin are used continuously or unused every day, but the fasting blood glucose is still above 140mmol/L and HbA1c is over 9; 5. Long-term application of anticoagulants or vitamin K antagonists, such as Hua Falin, heparin, or their analogues, is not included, but it does not include the use of small doses of Hua Falin (< < < 1mg / day) or aspirin for the purpose of prevention (less than 100mg/ days); 6. after 4 weeks of satisfaction, the serum CA125 level decreased less than 50% before operation or 2 months after operation; 7. During the first 4 weeks of the operation, there were major operations or surgical wounds were not completely healed; 8. previous toxicity of anti-tumor treatment caused, is still more than CTC AE 2; 9. when the clinical symptoms and signs are suspected of brain metastases, cranial MRI examination should be performed. If brain metastases are found, it is not possible to enter the group; 10. Combined malignant volume, ascites and ascites were not controlled; 11. in the past 5 years, there were other malignancies originated from histology, but the newly treated cervical cancer in situ and basal cell carcinoma or squamous cell carcinoma were excluded; 12. Within the first 1 weeks of admission, CFDA approved immune preparations or traditional Chinese medicines with antitumor indications; 13. before entering the group appeared within 4 weeks more than CTCAE grade 2 hemorrhage; 14. a long-term application of anticoagulants or vitamin K antagonists, such as Hua Falin, heparin or its analogues, is required for more than 6 months, but it does not include the use of small doses of Hua Falin (< < < 1mg / day) or aspirin for the purpose of prevention (less than 100mg/ days); 15. During the first 4 weeks of the group, they participated in any clinical trials of research drugs. 16. severe infection occurred within 1 weeks before the start of the study, requiring the use of antibiotics, antifungal or antiviral therapy. 17. patients with tuberculosis or HIV infection or HBV and HCV patients with abnormal liver function. 18. suffering from mental illness and poor compliance; 19. The researchers considered cases of unsuitable group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT;MTD;Effectiveness; | — |
Countries
China
Contacts
Public ContactWei Zhou
Guizhou Yibai pharmaceutical Co.,Ltd
Outcome results
None listed