A Study of Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Inoperable Locally Advanced or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events assessed by CTCAE v5.0
研究概览
简要总结
Pancreatic cancer is the 8th most prevalent cancer in Korea, and its 5-year overall survival rate has shown less than 10% due to its dismal prognosis. To date, the only curative treatment of pancreatic cancer is surgical resection. However, about 60% of patients with pancreatic cancer have been diagnosed as a locally advanced unresectable or metastatic disease at diagnosis owning to its difficulty in the early detection of cancer. The 5-year survival rate has been reported to be less than 25% even with surgical resection. Considering the high rate of metastasis and recurrence, systemic chemotherapy is essential to prolong survival. Therefore, Using AI platforms of RAPTOR (RNA expression-based Anti-symmetrical Pairing Tool for On-demand Response) and ReDRUG (Restoration using the drug for targeting unbalanced gene) developed by Oncocross, Chlorphenesin carbamate, and Hydroxychloroquine were discovered as candidate drugs having anti-metastatic effects.
This study aimed to evaluate the efficacy and safety of hydroxychloroquine and chlorphenesin carbamate in combination with mFOLFIRINOX in patients with inoperable locally advanced or metastatic pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of age ≥ 19 and < 80 years
- •A patient who meets any of the following criteria at the time of screening or before, and who is scheduled to receive chemotherapy with modified FOLFIRINOX for the first time after screening
- •Locally advanced inoperable pancreatic cancer
- •Metastatic pancreatic cancer
- •One or more measurable lesions by RECIST v 1.1
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 pr 1
- •Estimated life expectancy of at least 12 weeks or more at the discretion of the investigator
排除标准
- •History of major surgery within 4 weeks at the time of screening
- •Symptomatic, uncontrolled brain metastasis or meningeal carcinomatosis
- •History of malignancy within 5 years at the time of screening
- •History of human immunodeficiency virus (HIV) or active hepatitis
- •Active infection requiring systemic antibiotic therapy
- •Patients who have maculopathy or are receiving treatment for corneal or retinal disease, or under follow-up
- •History of acute or subacute intestinal obstruction or paralytic ileus, or a history of chronic diarrhea considered clinically significant at the discretion of the investigator
- •Serious neurological, psychiatric condition including drug abuse or alcoholism, which would prevent the subject from participating in the study
- •Patients with any condition who are considered unsuitable for participation in the study in the judgment of the investigator
研究组 & 干预措施
mFORFIRINOX, Chlorphenesin Carbamate, Hydroxychloroquine
干预措施: Chlorphenesin Carbamate, Hydroxychloroquine (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events assessed by CTCAE v5.0
时间窗: up to 3 years
次要结局
- Objective Response Rate(up to 3 years)
- Rate of Distant Metastasis-Free Survival(6, 12 months)
- Rate of Progression-Free Survival(6, 12 months)
- Overall Survival(up to 3 years)
研究者
Changhoon Yoo
Associate Professor
Asan Medical Center