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

NCT04590625 | Unknown Phase 2

• 1 other identifier: Arise-FJ-O001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• R0 resection rate

  defined as the proportion of patients with no gross tumor tissue residual after interval cytoreductive surgery

  approximately 2 years

• Progression-free survival

  defined as time from first administration of first-line therapy to documented disease progression

  approximately 2 years

Study Arms (2)

Group1

EXPERIMENTAL

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.

Drug: Apatinib Mesylate; Drug: Abraxane; Drug: Cis Platinum; Drug: Carboplatin

Group2

EXPERIMENTAL

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.

Drug: Apatinib Mesylate; Drug: Abraxane; Drug: Cis Platinum; Drug: Carboplatin

Interventions

Apatinib Mesylate DRUG

apatinib one course will last 21 days.Oral administration at a dose of 250 mg, qd

Group1; Group2

Abraxane DRUG

abraxane one course will last 21 days.Intravenously guttae at a dose of 260 mg/m2,d1

Group1; Group2

Cis Platinum DRUG

cis-platinum one course will last 21 days.cis-platinum introperitoneal injection at a dose of 75-100 mg/m2,d1

Group1; Group2

Carboplatin DRUG

carboplatin one course will last 21 days.carboplatin intravenous injection at a dose of AUC=5-6,d1

Group1; Group2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Blood routine examination standard:(without blood transfusion within 14 days before enrollment)
• Hb ≥ 100g/L，
• WBC ≥ 3.0×109/L
• ANC ≥ 1.5×109/L，
• PLT ≥ 100×109/L；
• Biochemical examination shall meet the following standards:
• BIL ≤ 1.5 times the upper limit of normal(ULN);
• ALT and AST ≤ 3 ×upper limit of normal(ULN);
• Serum creatinine Cr ≤ 1ULN;
• 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.
• Subjects voluntarily joined the study, signed informed consent, good compliance, and followed up;

You may not qualify if:

• Women who are pregnant or breastfeedind;
• Except for other malignant tumors, basal cell carcinoma of the skin and cervical cancer in situ in the past 5 years;
• Patients with symptomatic brain metastasis;Significant neurological or psychiatric disorders;
• Patients who have participated in other clinical trials in recent three months;
• Prior treatment with apatinib or other anti-vascular drugs and other small molecule tyrosine kinase inhibitors;
• Patients who have undergone systemic chemotherapy, radiotherapy, surgery, hormone therapy, or immunotherapy before enrollment;
• Within 3 months before treatment, there were esophageal (gastric fundus) varicose bleeding, intestinal obstruction and gastrointestinal perforation;
• Patients had clinically demonstrated cancerous ascites or pleural effusion;
• Patients has active infection or unexplained fever ≥38.5℃ within 7 days before enrollment;
• Severe liver, kidney, heart, lung, brain and other major organ failure;
• 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;
• 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;
• 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;
• Urine protein ≥ ++ or confirmed 24 hour urine protein quantitation;
• 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;

Sponsors & Collaborators

• Zhongshan Hospital Xiamen University: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

apatinib; Albumin-Bound Paclitaxel; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Officials

• Li Xiao, Doctor

  Zhongshan Hospital Xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Xiao, Doctor

CONTACT

2292201; xiaolibohan@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2020
• First Posted: October 19, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2023
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)