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 — DRUGApatinib (850 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.
- Paclitaxel-based chemotherapeutic regimens — DRUGPaclitaxel-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 ]