Biomarker-Integrated Umbrella, Advanced Gastric Cancer

Yonsei University400 enrolled

Overview

In-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment. The investigators initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.

In-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment.The investigators initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

400

Conditions

Gastric Cancer

Interventions

biomarker screeningOTHER

immunohistochemistry and in situ hybridization

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer 2. Eastern Cooperative Oncology Group performance status of 0 to 1 3. Male or female; ≥ 19 years of age 4. On or progression after 1st line palliative chemotherapy 5. Subjects with evaluable lesion (using RECIST 1.1 criteria) 6. Subjects who meet the following criteria: * Absolute neutrophil count ≥ 1000 /µL * Platelet count ≥ 75,000/ µL * Serum creatinine \< 1.5 x upper limit of normal or Creatinine clearance ≥60 mL/min * aspartate aminotransferase and alanine transaminase 3 x upper limit of normal Exclusion Criteria: * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

Locations (1)

Severance Hospital, Yonsei University Health System, Yonsei Cancer Center

Seoul, South Korea

Outcomes

Primary Outcomes

progression free survival

Time frame: 6 weeks

Data from ClinicalTrials.gov

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