Apatinib Treatment as the Neoadjuvant Therapy in Advanced Colorectal Cancer

Sponsor
Sichuan Provincial People's Hospital
Study ID
NCT03377842
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • FOLFOX regimen — DRUG
    FOLFOX(Oxaliplatin 85 mg/m² IV infusion and leucovorin 200 mg/m² IV infusion， followed by Fluorouracil 400 mg/m² IV bolus , followed by Fluorouracil 600 mg/m²/h IV infusionas a 22-hour continuous infusion). Repeat cycle every 2 weeks for a total of 6 cycl
  • apatinib and FOLFOX regimen — DRUG
    Apatinib, 500mg p.o. qd, Repeat cycle every 2 weeks for a total of 6 cycles. FOLFOX regime, Repeat cycle every 2 weeks for a total of 6 cycles.

Study Details

Apatinib has been proved to be effective and safe among patients in advanced colorectal cancer in several trials. the investigators aimed to evaluate its efficacy and safety as the neoadjuvant therapy in real world practice, and to explore factors associated with efficacy.

Key Dates

Start date
Jan 31, 2018
Status verified
Dec 2017
Primary completion
Aug 1, 2020
Completion
Sep 1, 2020

Study Design

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

Arms

  • Active Comparator: FOLFOX regimen
    FOLFOX regime alone.
  • Experimental: Apatinib and FOLFOX regimen
    Apatinib combine with FOLFOX regimen.

Primary Outcome Measure

R0 ,R1 or R2 resection [ Time Frame: at least 4-6 weeks after the end of chemotherapy ]

Central Contacts

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