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

Sponsor
Zhongshan Hospital Xiamen University
Study ID
NCT04590625
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 31, 2020
Status verified
Oct 2020
Primary completion
Oct 31, 2022
Completion
Dec 31, 2023

Study Design

Enrollment
58 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

R0 resection rate [ Time Frame: approximately 2 years ]

Central Contacts

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