Clinical Trials Logo

Clinical Trial Summary

This is a retrospective, multicenter, non-interventional study for the evaluation of real-world efficacy and safety of ramucirumab plus paclitaxel in gastric or gastroesophageal junction adenocarcinoma as part of the establishment of hospital medical record collection system to evaluate drug effectiveness by Health Insurance Review & Assessment Service (HIRA). The medical records in approximately 1400 patients with locally-advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, who have received ramucirumab plus paclitaxel combination therapy will be collected.


Clinical Trial Description

Ramucirumab plus paclitaxel combination therapy has shown a survival benefit in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. However, the real-world efficacy and safety of ramucirumab plus paclitaxel combination therapy in Korea have only been evaluated once outside of controlled clinical trials. Therefore, this large multicenter retrospective analysis was designed to evaluate the real-world efficacy and safety of ramucirumab plus paclitaxel under the Korea National Health Insurance System. The medical records in approximately 1400 patients with locally-advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, who have received ramucirumab plus paclitaxel combination therapy between May 2018 and December 2018 will be collected. Eligibility criteria included age ≥ 19 years, histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma, locally advanced unresectable or metastatic disease, and previous first-line systemic therapy including fluoropyrimidine and platinum. Efficacy was evaluated by overall survival, progression free survival, time to progression, objective response rate, disease control rate, and duration of response. Safety was evaluated by hematologic or non-non hematologic toxicities and adverse events of special interest with ramucirumab plus paclitaxel combination therapy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04192734
Study type Observational
Source Hallym University Medical Center
Contact
Status Completed
Phase
Start date December 18, 2019
Completion date October 30, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT04098796 - PD-1 Antibody + XELOX in 1st Line Serum A-fetoprotein (AFP)-Elevated Gastric or Gastroesophageal Junction Adenocarcinoma Phase 2
Completed NCT03849469 - A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors Phase 1
Active, not recruiting NCT03752398 - A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3) Phase 1
Recruiting NCT05994456 - Neoadjuvant Toripalimab for dMMR/MSI-H Gastric Cancer Phase 2
Completed NCT02340975 - A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma Phase 1/Phase 2
Recruiting NCT05482893 - PT886 For Treatment of Patients With Metastatic/Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinoma (the TWINPEAK Study) Phase 1/Phase 2
Active, not recruiting NCT05941481 - Neoadjuvant Chemo-hypoRT Plus PD-1 Antibody (Tislelizumab) in Resectable LA-G/GEJ Phase 2
Completed NCT03517488 - A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors Phase 1
Not yet recruiting NCT05218148 - SOX Combined With Sintilimab and Trastuzumab Versus SOX Regimen in the Perioperative Treatment of HER2-positive Locally Advanced Gastric Adenocarcinoma Phase 2