Real-world Data (RWD) of Ramucirumab Plus Paclitaxel

Study Overview
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Brief Summary
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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.

Detailed Description
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Most drugs are introduced into the medical market based on efficacy derived from randomized controlled trials (RCTs) in a subset of patient groups in which the age, presence of comorbidities, and general conditions of the target patient are strictly controlled by the researcher. 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 have collected retrospective RWD from patients who used ramucirumab/paclitaxel in a previous study (KCSG ST19-16). Considering the limitations of RWD obtained through retrospective data collection, it is necessary to generate RWE through RWD, which prospectively collects various clinical data obtained in the process of using new anticancer drugs.

Official Title
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A Prospective Study for Real-world Data (RWD) of Ramucirumab Plus Paclitaxel in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Conditions
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Gastric Cancer, Gastroesophageal Junction Adenocarcinoma

Intervention / Treatment
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* Drug: Ramucirumab and paclitaxel
* Drug: Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapy


Participation Criteria
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Eligibility Criteria
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Prospective population Inclusion Criteria: Patients aged 19 years or older and histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma Patients with locally advanced or metastatic disease for which curative resection is not possible. Patients who have failed fluoropyrimidine and platinum (cisplatin or oxaliplatin)-based chemotherapy as palliative first-line therapy Patients who is starting ramucirumab/paclitaxel combination therapy after the study initiation date Exclusion Criteria: Patients receiving ramucirumab monotherapy Patients receiving ramucirumab/paclitaxel in clinical trial or receiving without being covered by health insurance Patients unable to communicate or incapable of understanding documents for patient report outcomes Historical retrospective population Inclusion Criteria: Patients aged 19 years or older and histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma Patients with locally advanced or metastatic disease for which curative resection is not possible 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 Exclusion Criteria: Patients receiving ramucirumab monotherapy Patients receiving ramucirumab/paclitaxel in clinical trial or receiving without being covered by health insurance

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective population<br>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 | Drug: Ramucirumab and paclitaxel<br>* Ramucirumab/paclitaxel as a second-line chemotherapy after May 1, 2018, when health insurance coverage for the combination therapy started<br>* Other names: Prospective population;|
| Historical retrospective population<br>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. | Drug: Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapy<br>* Taxane, irinotecan , or fluoropyrimidine-based single or combined chemotherapy as a second-line therapy<br>* Other names: Historical retrospective population;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from the start of ramucirumab/paclitaxel to death from any cause | Until September 30, 2023 | 
| Progression-free survival | Time from the start of ramucirumab/paclitaxel to disease progression or death from any cause | Until September 30, 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Number (percentage) of subjects reporting adverse events according to CTCAE v5.0 | Until September 30, 2023 | 
| Time to progression | Time from the start of ramucirumab/paclitaxel to disease progression | Until September 30, 2023 | 
| Objective response rate | The proportion of subjects confirmed complete or partial response according to RECIST v1.1 | Until September 30, 2023 | 
| Disease control rate | The proportion of subjects confirmed complete response, partial response or stable disease according to RECIST v1.1 | Until September 30, 2023 | 
| Duration of response | Time from documentation of tumor response to disease progression | Until September 30, 2023 | 
| Adverse events of special interest | Number (percentage) of subjects reporting adverse events of special interest associated with ramucirumab/paclitaxel: hypertension, proteinuria, gastrointestinal bleeding or perforation, delayed wound healing, deep vein thrombosis, arterial thrombosis, stroke according to on CTCAE v5.0 | Until September 30, 2023 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Real-world data, Gastric cancer, Gastroesophageal junction adenocarcinoma, Ramucirumab, Paclitaxel, Chemotherapy