Status:
NOT_YET_RECRUITING
Maintenance Therapy After Platinum-containing Chemotherapy in Patients With Recurrent Ovarian Cancer
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
Thirty-seven women aged 18-75 years with recurrent ovarian cancer were enrolled
Detailed Description
The subjects selected surgery according to the actual situation, and received chemotherapy containing platinum after surgery, totaling 4 cycles of chemotherapy. After the completion of the treatment c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Other clinical drug experiments in which other experimental drugs are used at the same time as the study;
- 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;
- 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 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;
- The patient has a prior or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
- Recent (within 3 months) occurrence of intestinal obstruction, gastrointestinal perforation;
- 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;
- Any bleeding event with a severe CTCAE 5.0 rating of 2 or more occurring within 4 weeks prior to the initial trial administration;
- People with hypertension who are not well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
- 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 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;
- Diagnosis of patients with deep vein thrombosis (except intermuscular vein thrombosis);
- 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;
- 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);
- The patient received platelet or red blood cell transfusions within four weeks prior to initiation of treatment with the investigational drug;
- 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.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT06188455
Start Date
December 1 2024
End Date
December 1 2026
Last Update
January 3 2024
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