Neoadjuvant Chemo-hypoRT Plus PD-1 Antibody (Tislelizumab) in Resectable LA-G/GEJ
NCT05941481
Gastric or Gastroesophageal Junction Adenocarcinoma
Nanjing, Jiangsu, China
View Trial DetailsNCT Number: NCT04192734
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.
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All sexes
Observational
Korea University Ansan Hospital, Ansan, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Until September 30, 2019
Time from the start of ramucirumab plus paclitaxel to death from any cause
Time frame: Until September 30, 2019
Time from the start of ramucirumab plus paclitaxel to disease progression or death from any cause
Time frame: Until September 30, 2019
Number (percentage) of subjects reporting adverse events
Time frame: Until September 30, 2019
Time from the start of ramucirumab plus paclitaxel to disease progression
Time frame: Until September 30, 2019
The proportion of subjects confirmed complete or partial response
Time frame: Until September 30, 2019
The proportion of subjects confirmed complete or partial response or stable disease
Time frame: Until September 30, 2019
Time from documentation of tumor response to disease progression
Time frame: Until September 30, 2019
Number (percentage) of subjects reporting adverse events of special interest associated with ramucirumab plus paclitaxel
Hallym University Medical Center
Other
A Retrospective Study for Evaluation of Real-world Efficacy and Safety of Ramucirumab Plus Paclitaxel in Patients With Locally-advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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