Molecularly Target Therapy With GEMOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma

Sponsor
Shanghai Jiao Tong University School of Medicine
Study ID
NCT02836847
Phase
PHASE2
Status
Unknown

Conditions

  • Cholangiocarcinoma of the Extrahepatic Bile Duct
  • Gallbladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • biological test — PROCEDURE
    mutation and signal pathway activation status analysis
  • GEMOX — DRUG
    Conventional chemotherapy:gemcitabine and oxaliplatin
  • Cetuximab — DRUG
  • Trastuzumab — DRUG
  • Gefitinib — DRUG
  • Lapatinib — DRUG
  • Everolimus — DRUG
  • Sorafenib — DRUG
  • Crizotinib — DRUG

Study Details

The purpose of this study is to evaluate the feasibility, efficacy and safety of target therapy according to genomic and proteomic profiling combined with GEMOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.

Key Dates

Start date
Jul 31, 2016
Status verified
May 2018
Primary completion
Dec 31, 2019
Completion
Dec 31, 2020

Study Design

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

Arms

  • Experimental: target therapy
    The patients wil receive conventional chemotherapy(GEMOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.
  • Other: GEMOX
    The patients wil receive conventional chemotherapy(GEMOX).

Primary Outcome Measure

Progression Free Survival [ Time Frame: up to 1 year ]

Central Contacts

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