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
试验速览
- 阶段
- 不适用
- 入组人数
- 222
- 试验地点
- 9
- 主要终点
- Overall survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Ramucirumab and paclitaxel (Drug)
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.
干预措施: Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapy (Drug)
结局指标
主要结局
Overall survival
时间窗: Until September 30, 2023
Time from the start of ramucirumab/paclitaxel to death from any cause
Progression-free survival
时间窗: Until September 30, 2023
Time from the start of ramucirumab/paclitaxel to disease progression or death from any cause
次要结局
- Duration of response(Until September 30, 2023)
- Time to progression(Until September 30, 2023)
- Adverse events of special interest(Until September 30, 2023)
- Incidence of adverse events(Until September 30, 2023)
- Objective response rate(Until September 30, 2023)
- Disease control rate(Until September 30, 2023)
研究者
Zang, Dae Young
Professor
Hallym University Medical Center