Apatinib Combined With S-1 in the Second-line Treatment of Advanced Pancreatic Cancer

Sponsor
Changzhou No.2 People's Hospital
Study ID
NCT03662035
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced Pancreatic Cancer

Eligibility Criteria

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

Interventions

  • Apatinib — DRUG
    Apatinib Patients with advanced pancreatic cancer after failure of first-line chemotherapy will receive Apatinib (500mg/d, orally) 30 minutes after meal with warm water.Take 21 days as a cycle, patients will receive this treatment until they have got disease progressed. Dose adjustment: with 3/4 level of adverse reactions, the dose should be lowered to 250 mg/d.
  • S-1 — DRUG
    S-1 Patients will receive S-1 (60mg/d for BSA\<1.25m2, 80mg/d for 1.25\<BSA\<1.5m2, and 100mg for BSA \>1.5m2, orally) twice a day, once after breakfast and once after dinner, for 14 days, 7 days for suspension and 21 days as one cycle.

Study Details

The aim of this study was to determine the efficacy and safety of apatinib combined with S-1 on advanced pancreatic cancer patients after failure of first-line chemotherapy.

Key Dates

Start date
Sep 15, 2018
Status verified
Sep 2018
Primary completion
Mar 1, 2020
Completion
Aug 1, 2020

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: single-arm
    Apatinib and S-1 Patients will be offered with Apatinib (500mg/d) and S-1 (60mg/d for BSA\<1.25m2, 80mg/d for 1.25\<BSA\<1.5m2, and 100mg for BSA \>1.5m2) until their disease have progressed.

Primary Outcome Measure

Progression Free Survival [ Time Frame: one year. ]