Clinical Study of Apatinib Combined With Second - Line Chemotherapy for Metastatic Colorectal Cancer

Sponsor
Liqiang Zhong
Study ID
NCT03412994
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    Apatinib in combination with standard second-line chemotherapy for advanced colorectal cancer
  • standard second-line chemotherapy — DRUG
    The second line standard chemotherapy regimen recommended by the NCCN

Study Details

(1) Evaluate the efficacy of apatinib in combination with standard second-line chemotherapy for advanced colorectal cancer. Whether it can prolong Progression Free Survival (PFS), overall survival (OS) in patients with advanced colorectal cancer and reduce symptoms and improve quality of life compared with standard second-line chemotherapy; (2) Observe the safety of apatinib for the treatment of advanced colorectal cancer.

Key Dates

Start date
Feb 28, 2018
Status verified
Jan 2018
Primary completion
Feb 28, 2020
Completion
Feb 28, 2021

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib group
    Apatinib combined with second-line chemotherapy (5-Fu combined with irinotecan or oxaliplatin standard regimen ) Apatinib tablets: 500 mg po qd . Continuous medication, the cycle is consistent with the chemotherapy cycle. Oxaliplatin: Day 1, 130mg/m2, IV infusion. Capecitabine: Day 1-14, 1000mg/m2 Twice Daily, po. A total of 6 cycles, 3 weeks apart of chemotherapy.（Take CAPEOX for example）
  • Placebo Comparator: Control group
    Oxaliplatin: Day 1, 130mg/m2, IV infusion. Capecitabine: Day 1-14, 1000mg/m2 Twice Daily, po. A total of 6 cycles, 3 weeks apart of chemotherapy.（Take CAPEOX for example）

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Approximately 2 year ]

Central Contacts

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