Clinical Trial of Apatinib Reverses Chemotherapy-Resistance of Patients With Advanced Gastric Cancer

Sponsor
Fujian Cancer Hospital
Study ID
NCT02697838
Phase
PHASE2
Status
Unknown

Conditions

  • Malignant Neoplasm of Stomach Stage II

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    Apatinib (850 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.
  • Paclitaxel-based chemotherapeutic regimens — DRUG
    Paclitaxel-based chemotherapeutic regimens including: 1. The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days. 2. The PF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days. 3. Paclitaxel 80mg/m2 d1,d8,d15,repeating the cycle every 28 days 4. other paclitaxel-based regimens

Study Details

A single arm study: Apatinib plus paclitaxel as the reverses treatment in advanced gastric cancer which paclitaxel-resistant.

Key Dates

Start date
Aug 1, 2016
Status verified
Oct 2018
Primary completion
Mar 31, 2018
Completion
Oct 31, 2018

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Apatinib plus chemotherapy

Primary Outcome Measure

disease control rate(DCR) [ Time Frame: 6 months ]