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Apatinib Combined With Abraxane and Carboplatin or Cisplatinum as First-line Treatment for Epithelial Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT04590625
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Zhongshan Hospital Xiamen University

Tracking Information
First Submitted Date  ICMJE October 10, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date October 19, 2020
Estimated Study Start Date  ICMJE October 2020
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2020)
  • R0 resection rate [ Time Frame: approximately 2 years ]
    defined as the proportion of patients with no gross tumor tissue residual after interval cytoreductive surgery
  • Progression-free survival [ Time Frame: approximately 2 years ]
    defined as time from first administration of first-line therapy to documented disease progression
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Apatinib Combined With Abraxane and Carboplatin or Cisplatinum as First-line Treatment for Epithelial Ovarian Cancer
Official Title  ICMJE Apatinib Mesylate Combined With Albumin Binds Paclitaxel and Carboplatin or Cisplatinum as First-line Treatment for Stage II-IV Epithelial Ovarian Cancer Followed by Apatinib Maintenance Therapy:a Single-arm,Exploratory Clinical Study
Brief Summary This monocentric, prospective, observational study will evaluate the safety and efficacy of apatinib in combination with albumin binds paclitaxel and carboplatin or cisplatinum as first-line treatment for stage II-IV epithelial ovarian cancer followed by apatinib maintenance therapy in routine clinical practice. Eligible patients will be followed for approximately 20 months.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: Apatinib Mesylate
    apatinib one course will last 21 days.Oral administration at a dose of 250 mg, qd
  • Drug: Abraxane
    abraxane one course will last 21 days.Intravenously guttae at a dose of 260 mg/m2,d1
  • Drug: Cis Platinum
    cis-platinum one course will last 21 days.cis-platinum introperitoneal injection at a dose of 75-100 mg/m2,d1
  • Drug: Carboplatin
    carboplatin one course will last 21 days.carboplatin intravenous injection at a dose of AUC=5-6,d1
Study Arms  ICMJE
  • Experimental: Group1
    1. Neoadjuvant therapy:

      Apatinib:apatinib one course will last 21 days.Oral administration at a dose of 250 mg, qd; Abraxane:abraxane one course will last 21 days.Intravenously guttae at a dose of 260 mg/m2,d1; Cis-platinum or Carboplatin:cis-platinum or carboplatin one course will last 21 days.cis-platinum introperitoneal injection at a dose of 75-100 mg/m2,d1;carboplatin intravenous injection at a dose of AUC=5-6,d1.

      Neoadjuvant therapy is 3-4 cycles.After Neoadjuvant therapy will received interval cytoreductive surgery.

    2. Adjuvant therapy:

      After interval cytoreductive surgery,patients will received adjuvant therapy same as neoadjuvant therapy.

      Adjuvant therapy is 3 cycles

    3. maintenance treatment: After above treatment finished,patients will received aptinib for 2 years.
    Interventions:
    • Drug: Apatinib Mesylate
    • Drug: Abraxane
    • Drug: Cis Platinum
    • Drug: Carboplatin
  • Experimental: Group2

    1.Adjuvant therapy:

    After primary cytoreductive surgery,patients will received adjuvant therapy:

    Apatinib:apatinib one course will last 21 days.Oral administration at a dose of 250 mg, qd; Abraxane:abraxane one course will last 21 days.Intravenously guttae at a dose of 260 mg/m2,d1; Cis-platinum or Carboplatin:cis-platinum or carboplatin one course will last 21 days.cis-platinum introperitoneal injection at a dose of 75-100 mg/m2,d1;carboplatin intravenous injection at a dose of AUC=5-6,d1.

    Adjuvant therapy is 3 cycles 3.maintenance treatment: After above treatment finished,patients will received aptinib for 2 years.

    Interventions:
    • Drug: Apatinib Mesylate
    • Drug: Abraxane
    • Drug: Cis Platinum
    • Drug: Carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2020)
58
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-

1.Age 18 - 75 years; 2.Histologically confirmed, stage II or IV epithelial ovarian carcinoma; 3.For Group1,patients with stage III-IV ovarian cancer who are considered unlikely to achieve satisfactory tumor reduction after preoperative evaluation by gynecological oncologists or not suitable for direct surgery are required; 4.Patients with at least one evaluable or measurable lesions as per RECIST version 1.1(CT scan length and diameter of tumor lesion≥10mm CT scan of lymph node lesion was short diameter≥15mm,scan slice thickness 5mm); 5.ECOG performance status (PS) 0 - 2; 6.Life expectancy of at least 12 weeks; 7.Patients with adequate organ function at the time of enrollment as defined below:

  1. Blood routine examination standard:(without blood transfusion within 14 days before enrollment)

    1. Hb ≥ 100g/L,
    2. WBC ≥ 3.0×109/L
    3. ANC ≥ 1.5×109/L,
    4. PLT ≥ 100×109/L;
  2. Biochemical examination shall meet the following standards:

    1. BIL ≤ 1.5 times the upper limit of normal(ULN);
    2. ALT and AST ≤ 3 ×upper limit of normal(ULN);
    3. Serum creatinine Cr ≤ 1ULN;
    4. Serum creatinine ALB ≥ 30g/L. 8.Women of childbearing age in the serum or urine pregnancy test is negative within 7 days prior to study enrollment and must be Non-lactating patients,and agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 8 months after the end of the study; males should agree to patients who must use contraception during the study period and within 8 months after the end of the study period.

      9.Subjects voluntarily joined the study, signed informed consent, good compliance, and followed up;

      Exclusion Criteria:

      1. Women who are pregnant or breastfeedind;
      2. Except for other malignant tumors, basal cell carcinoma of the skin and cervical cancer in situ in the past 5 years;
      3. Patients with symptomatic brain metastasis;Significant neurological or psychiatric disorders;
      4. Patients who have participated in other clinical trials in recent three months;
      5. Prior treatment with apatinib or other anti-vascular drugs and other small molecule tyrosine kinase inhibitors;
      6. Patients who have undergone systemic chemotherapy, radiotherapy, surgery, hormone therapy, or immunotherapy before enrollment;
      7. Within 3 months before treatment, there were esophageal (gastric fundus) varicose bleeding, intestinal obstruction and gastrointestinal perforation;
      8. Patients had clinically demonstrated cancerous ascites or pleural effusion;
      9. Patients has active infection or unexplained fever ≥38.5℃ within 7 days before enrollment;
      10. Severe liver, kidney, heart, lung, brain and other major organ failure;
      11. Patients with hypertension that is difficult to control (systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg) despite treatment with several hypotensive agents;
      12. Previous or current had idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, histopathological pneumonia (e.g., bronchitis, obliterans), drug-induced pneumonia, or screening stage CT with active pneumonia;
      13. Patients with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds), bleeding tendency or receiving thrombolytic or anticoagulant therapy are allowed to receive low-dose LMWH or oral aspirin to prevent anticoagulant therapy during the trial;
      14. Urine protein ≥ ++ or confirmed 24 hour urine protein quantitation;
      15. Patients with cardiac clinical symptoms or diseases that are not well controlled,such as:(1) NYHA2 or above heart failure;(2) Unstable angina;(3) Myocardial infarction occurred within 1 year;(4) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention;(5) QTc > 470ms;
      16. Inability to swallow pills, malabsorption syndrome, or any condition that affects gastrointestinal absorption;
      17. In the 6 months prior to enrollment, patients had been arteriovenous thrombosis (AVT), such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis (DVT) and pulmonary embolism;
      18. Patients with a history of hereditary or acquired bleeding or coagulation disorders.There were clinically significant bleeding symptoms or definite bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding and hemorrhagic gastric ulcer;
      19. According to the judgment of the researcher, the patients have other factors that may lead to the forced termination of this study, such as other serious diseases (including mental diseases) requiring combined treatment, severe laboratory test abnormalities, accompanied by family or social factors, which will affect the safety of the subjects, or the collection of data.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Li Xiao, Doctor 2292201 ext 0592 xiaolibohan@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04590625
Other Study ID Numbers  ICMJE Arise-FJ-O001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zhongshan Hospital Xiamen University
Study Sponsor  ICMJE Zhongshan Hospital Xiamen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Li Xiao, Doctor Zhongshan Hospital Xiamen University
PRS Account Zhongshan Hospital Xiamen University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP