Clinical Outcomes of Intravenous Vitamin C Synergy With Tyrosine Kinase Inhibitor in Lung Adenocarcinoma Patients With Epidermal Growth Factor Receptor Mutations
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
This trial was to explore whether intravenous vitamin C can prolong resistance time of Tyrosine Kinase Inhibitor(TKI) on lung adenocarcinoma patients with Epidermal Growth Factor Receptor(EGFR) mutations, and can benefit NSCLC patients.
详细描述
The effects of vitamin C in combination with tyrosine kinase inhibitor on tumor size, tumor markers, inflammatory factor levels, quality of life, duration of resistance, progression-free survival, and overall survival time were evaluated.
This trial is a low risk treatment, and has developed the appropriate safety measures and contingency plans to ensure patients' safety in the whole process.
Patients will be followed up after the end of the trial, and follow-up observations will be performed every month during the first year. Followed every 3 months in the second year for 3 years.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary non-small cell lung cancer (adenocarcinoma) with EGFR mutations on exons 19 and
- •18 years old to 75 years old.
- •During the trial, patients were prescribed TKI drugs(received initial treatment within 2 months, or change medication within 2 months) and did not receive chemotherapy or radiotherapy at the same time.
- •Eastern Cooperative Oncology Group (ECOG) performance status are 0 to
- •Expected survival over 3 months.
- •Household registration is Guangdong Province.
排除标准
- •Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), and uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.
- •Glucose-6-phosphate dehydrogenase deficiency (G6PD) (a relative contraindication).
- •Patients who are allergic to vitamin C.
- •Patients with HIV and other infectious diseases.
- •Patients who are taking anticoagulants and have coagulopathy;
- •Combine dysfunction of important organs such as heart, lung, liver and kidney;
- •Patients with impaired renal function (serum creatinine content > 1.2 mg/dL)
- •Compromised liver function with evidence of Serum total bilirubin content, Serum alanine aminotransferase(ALT) and aspartate transaminase(AST)> 2 times normal reference value.
- •Pregnant or lactating female.
- •Smoking and alcohol abuse patients;
- •Anti-infective treatment is required for systemic or localized serious infections;
- •Patients with hyperuricacidemia (normal: 91-456 μmol / 24h (8-40mg / 24h));
- •Wilson's disease.
- •Evidence of significant psychiatric disorder by history or examination that would prevent completion of the study or preclude informed consent.
- •Any condition that impairs the patients' ability to swallow, which impairs drug absorption or drug kinetic parameters, including any kind of gastrointestinal resection or surgery;
- •History of surgery of visceral organs within 6 weeks before the study.
研究组 & 干预措施
Experimental group
75 patients received a weekly intravenous Vitamin C injection (dose: 30 g / time, once a week, treatment termination when the disease progress is confirmed) in combination with daily taking tyrosine kinase inhibitor.
干预措施: Vitamin C (Drug)
Experimental group
75 patients received a weekly intravenous Vitamin C injection (dose: 30 g / time, once a week, treatment termination when the disease progress is confirmed) in combination with daily taking tyrosine kinase inhibitor.
干预措施: Tyrosine kinase inhibitor (Drug)
Control group
75 patients received tyrosine kinase inhibitor daily. (dose: Osimertinib 80 mg/d, or Tarceva 150 mg/d, or Iressa 0.25 g/d.)
干预措施: Tyrosine kinase inhibitor (Drug)
结局指标
主要结局
Progression free survival
时间窗: From the start date of treatment until the date of first documented progression or death, assessed up to 2 years
From the start of treatment until the patient has tumor progression or death
次要结局
- Overall survival(From the start date of treatment until the date of death from any cause, assessed up to 2 years.)