Maintenance Therapy After Platinum-containing Chemotherapy in Patients With Recurrent Ovarian Cancer

Korábbi kezelés

• Other clinical drug experiments in which other experimental drugs are used at the same time as the study;
• Symptomatic or uncontrolled brain metastases requiring concurrent treatment, including but not limited to surgery, radiation and/or corticosteroids, or clinical manifestations of spinal cord compression;
• The patient has a prior or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
• Any bleeding event with a severe CTCAE 5.0 rating of 2 or more occurring within 4 weeks prior to the initial trial administration;
• Previous or current idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, institutionalized pneumonia, drug-induced pneumonia, or active pneumonia shown by CT during screening;
• Patients with a history of hereditary or acquired bleeding or coagulation disorders. There were clinically significant bleeding symptoms or definite bleeding tendencies within 3 months before the first trial, such as gastrointestinal bleeding and hemorrhagic gastric ulcer;

Más betegség

• Other cancer treatments, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, microbiological therapy, traditional Chinese medicine therapy and other experimental therapies, were used in conjunction with this study;
• Patients who are known to be allergic to fluzoparil or to active or inactive components of the drug with a similar chemical structure;
• Patients who are known to be allergic to Apatinib or to active or inactive components of the drug with a similar chemical structure;
• Inability to swallow oral medications and any gastrointestinal disorders that may interfere with study drug absorption and metabolism, such as uncontrolled nausea and vomiting, gastrointestinal obstruction, or malabsorption;
• The subject has had other malignant diseases in the past 3 years, except cutaneous squamous cell carcinoma, basal-like carcinoma, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix;
• Recent (within 3 months) occurrence of intestinal obstruction, gastrointestinal perforation;
• People with hypertension who are not well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
• Diagnosis of patients with deep vein thrombosis (except intermuscular vein thrombosis);
• Subjects with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA≥500 IU/ml; Hepatitis C reference: HCV antibody positive and HCV copy number > upper limit of normal);

Laborértékek

• Patients with clinical symptoms or diseases that are not well controlled, such as: (1) NYHA2 or above cardiac dysfunction, (2) unstable angina pectoris, (3) acute myocardial infarction occurred within 1 year, (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, (5) QTc>470ms;
• Patients with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds) who have bleeding tendencies or are receiving thrombolytic or anticoagulant therapy (including but not limited to patients requiring long-term anticoagulant therapy) are allowed to receive low-dose low-molecular weight heparin or oral aspirin prophylactic anticoagulant therapy during the trial;
• The patient received platelet or red blood cell transfusions within four weeks prior to initiation of treatment with the investigational drug;

Egyéb

• Patients who are pregnant or nursing, or who plan to become pregnant during the study treatment period.
• According to the researchers' judgment, the subjects have other factors that may lead to the forced termination of the study.

• 1. Age: 18 ≤75 years old, female; 2. Pathological (including histological) evidence of ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer (ovarian cancer); 3. Received first-line platinum drug chemotherapy in the past, the curative effect during the last treatment with platinum regimen (from the start of treatment to within 1 month after the last administration) was non-PD, and the recurrence/progression (platinum resistance) within 6 months after the end of treatment; Or recurrence or progression (platinum-sensitive) ≥6 months after the end of the last platinum-containing treatment; CR/PR/SD after at least 4 cycles of chemotherapy again; 4. According to RECIST1.1 criteria, the patient had at least one target lesion with measurable diameter (tumor lesion with CT scan length ≥10mm, lymph node lesion with CT scan short diameter ≥15mm, and scanning layer thickness 5mm); 5. ECOG PS 0-1 score; 6. Major organs function normally and meet the following criteria:
  • The standard of blood routine examination must meet: (no blood transfusion within 14 days)
  • HB≥100g/L,
  • WBC≥3×109/L
  • ANC≥1.5×109/L,
  • PLT≥100×109/L;
  • Biochemical examination shall meet the following standards:
  • BIL ≤1.5 times upper limit of normal value (ULN);
  • ALT and AST≤2.5×ULN, and ALT and AST≤5×ULN in patients with liver metastasis;
  • Serum Cr≤1.5×ULN. 7. International Standardized ratio (INR) OR prothrombin time (PT), activated partial thrombin activity time (aPTT)≤1.5 × ULN, unless the patient is receiving anticoagulant therapy, as long as PT or aPTT is within the therapeutic range of the anticoagulant drug intended to be used; 8. No serious heart, lung, liver, kidney disorders; 9. Women of reproductive age must undergo a pregnancy test (serological) within 7 days prior to enrollment, with a negative result, and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last dose of the test drug; 10. The expected overall survival ≥6 months, post-treatment survival ≥3 months; 11. Sign a written informed consent and be able to comply with the visit and related procedures specified in the program.