Overview

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

Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhongshan Hospital Xiamen University
Treatments:
Albumin-Bound Paclitaxel
Apatinib
Carboplatin
Cisplatin
Criteria
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.