NCT04698915终止2 期
GRECO-2: A Randomized, Phase 2b Study of GC4711 in Combination With Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Unresectable or Borderline Resectable Nonmetastatic Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 177
- 试验地点
- 35
- 主要终点
- Overall Survival
研究概览
简要总结
GTI-4711-201 is designed as a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the effect to OS by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained.
- •Newly diagnosed non-metastatic PC judged by tumor board to be feasible for SBRT
- •Completed at least 6 weeks of chemotherapy consisting of FOLFIRINOX, mFOLFIRINOX, or a gemcitabine-based doublet regimen prior to start of SBRT
- •Remain non-metastatic as confirmed by a CT scan at screening.
- •Female or male subjects ≥ 18 years of age
- •ECOG performance status of 0-2
- •Adequate end-organ function
排除标准
- •Subjects with documented metastatic disease
- •First-line chemotherapy other than FOLFIRINOX, mFOLFIRINOX, and/or a gemcitabine-based doublet regimen
- •Prior abdominal RT with substantial overlap in radiation fields
- •Subjects not recovered/controlled from treatment-related toxicities
- •Uncontrolled malignancy other than PC
- •Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing
- •Visible invasion of bulky tumor into the lumen of the bowel or stomach on endoscopy
研究组 & 干预措施
Arm A Active GC4711
Experimental
干预措施: Drug GC4711 (Drug)
Arm B Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival
时间窗: From randomization of the first subject until 30 days post last dose of GC4711/ and SBRT for the last subject randomized to the study (total duration 2years and 6.5 months)
Overall survival is defined as the time from randomization to the date of death from any cause. The number of subjects that have died during this time period is the reported outcome measure.
次要结局
未报告次要终点
研究者
研究点 (35)
Loading locations...
相似试验
终止
1 期
Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLCSBRTNon-metastaticNSCLCNCT04476797Galera Therapeutics, Inc.47
进行中（未招募）
2 期
Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisNCT06290934Gilead Sciences228
已完成
2 期
A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck CancerRadiation Induced Oral MucositisNCT02508389Galera Therapeutics, Inc.223
Unknown
2 期
A Phase 2b Study of GCS-100 in Patients With Chronic Kidney Disease Caused by DiabetesDiabetic Chronic Kidney DiseaseNCT02312050La Jolla Pharmaceutical Company375
已完成
2 期
A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)Glioblastoma MultiformeNCT01280552Precision Life Sciences Group124