Real-world Data (RWD) of Ramucirumab Plus Paclitaxel

Sponsor
Hallym University Medical Center
Study ID
NCT04915807
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Real World Data (RWD) obtained from real clinical sites is data obtained after administering a drug to patients with different characteristics in daily practice, and Real World Evidence (RWE) is established based on RWD. It is possible to overcome the disadvantage of RCT, which cannot reflect all the various variables in the actual clinical field as it is conducted for only subset of patients. Researchers planned to prospectively collect RWD of ramucirumab/paclitaxel combination therapy as 2nd-line chemotherapy in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Key Dates

Start date
Jun 30, 2021
Status verified
Jun 2021
Primary completion
Sep 30, 2022
Completion
Sep 30, 2023

Study Design

Enrollment
222 participants (estimated)

Arms

  • Arm: Prospective population
    The target group for the purpose of prospectively collecting the clinical data (RWD) of patients using ramucirumab/paclitaxel as 2nd-line chemotherapy in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
  • Arm: Historical retrospective population
    The target group for the purpose of retrospectively collecting the clinical data (RWD) of patients who have failed platinum-based palliative first-line therapy, and who started the following second-line therapy: taxane, irinotecan , or fluoropyrimidine-based single or combined chemotherapy, before May 1, 2018, when health insurance coverage for the ramucirumab/paclitaxel combination therapy started in South Korea.

Primary Outcome Measure

Overall survival [ Time Frame: Until September 30, 2023 ]

Central Contacts

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