Ovarian cancer
Conditions
Interventions
Trial group:Camrelizumab: 200mg, iv, 30min, q2w Chemotherapy: nab-paclitaxel 80mg/m2 d1, 8, 15 iv q4w, until death or intolerable toxicity treatment
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-70 years; 2. Patients with recurrent ovarian cancer diagnosed by histopathology or cytology; 3. Patients who have been treated with platinum based chemotherapy (relapse occurred during treatment or within 6 months after completion) 4. Patients with at least one measurable lesion; 5. ECoG PS score: 0-2 points; 6. Patients with survival time >= 3 months; 7. The function of the main organs is normal, that is to say, it meets the following standards: (1) Blood routine examination: HB >= 90 g/L ANC >= 1.5x 10^9/L PLT >= 100 x 10^9/L (2) Biochemical examination: ALB >= 29g/L ALT and AST < 3 x ULN, ALT and AST < 5 x ULN in patients with liver metastasis; TBIL <= 1.5 x ULN Creatinine <= 1.5 x ULN 8. The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients allergic to taxanes; 2. Patients who have used immunosuppressive drugs within 14 days before medication, excluding nasal and inhaled corticosteroids or systemic steroids with physiological doses (i.e. prednisolone not exceeding 10 mg / day or other corticosteroids with the same physiological dose of drugs) were excluded; 3. Patients with any active autoimmune disease or history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or asthma in childhood have been completely relieved, and no intervention is required in adults Asthmatics requiring medical intervention with bronchodilators could not be included; 4. Patients with other malignant tumors within 5 years; 5. Patients with HIV infection or known acquired immunodeficiency syndrome (AIDS), patients with active hepatitis B (HBV DNA >= 1000 IU / ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the analysis method) or patients with CO infection of hepatitis B and hepatitis C, who need antiviral treatment during the research process; 6. Patients with myocardial infarction, severe / unstable angina pectoris, NYHA grade 2 or above cardiac insufficiency, and arrhythmia (including QTCF interval > 450 ms, female > 470 MS) within 6 months before medication MS, QTCF interval was calculated by fridericia formula), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); 7. Patients with severe infection within 4 weeks before treatment (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs), or fever of unknown origin > 38.5 degrees C during screening / before first administration; 8. Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 9. Patients who participated in any other drug clinical study within 4 weeks before the first administration; 10. Patients who are known to have psychotropic substance abuse and are unable to quit or have mental disorders; 11. The patients are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS;OS;safety; | — |
Countries
china
Contacts
Public ContactHui zhang
The Fourth Hospital of Hebei Medical University
Outcome results
None listed