Apapitatin Combined With SOX for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma

Sponsor
Eastern Hepatobiliary Surgery Hospital
Study ID
NCT03702491
Phase
PHASE2
Status
Unknown

Conditions

  • Gallbladder Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    Three to four weeks after surgery, the SOX regimen was given palliative adjuvant chemotherapy for 6-8 cycles, then followed by the second cycle combined with the treatment of apatinib mesylate and the monotherapy maintenance of apatinib mesylate
  • Tegafur — DRUG
    3-4 weeks after operation, 6-8 cycles of adjuvant chemotherapy with simple SOX protocol were given.

Study Details

A Single-center Open, Randomized, Controlled Study to Compare the Apapitatin Mesylate Combined With SOX Regimen and SOX Regimen for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma

Key Dates

Start date
Aug 10, 2018
Status verified
Aug 2018
Primary completion
Aug 10, 2020
Completion
Aug 10, 2020

Study Design

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

Arms

  • Experimental: Apatinib with SOX(Tegafur,Oxaliplatin)
    Patients 3-4 weeks after surgery, the SOX regimen was given palliative adjuvant chemotherapy for 6-8 cycles, then followed by the second cycle combined with the treatment of apatinib mesylate and the monotherapy maintenance of apatinib mesylate
  • Active Comparator: SOX( Tegafur,Oxaliplatin)
    3-4 weeks after operation, 6-8 cycles of adjuvant chemotherapy with simple SOX protocol were given.

Primary Outcome Measure

PFS [ Time Frame: 12 month after first treatment ]

Central Contacts

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