KCT0006689Completed未知
Safety and efficacy of Bojungikki-tang in advanced NSCLC patients receiving treatment with immune checkpoint inhibitors: A study protocol for a multicenter, double-blind, randomized, placebo-controlled pilot trial
Koera University Guro Hospital0 sites30 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 19(Year) to o Limit (—)
- Sex
- All
Inclusion Criteria
- •1) Adult male and female aged 19 years old and above
- •2) (According to TNM 8th edition) patient diagnosed with stage IIIB, IIIC, or IV non-small cell lung cancer
- •3) Patient planned for single treatment of Atezolizumab, an immune checkpoint inhibitor, as second and subsequent line therapy under permission
- •- Patient with advanced or metastatic non-small cell lung cancer whose disease have progressed during or after approved platinum-based chemotherapy
- •- Patients with EGFR or ALK mutant who are confirmed disease progression after approved treatment for these mutations and have failed prior platinum-based chemotherapy
- •4) Patient who is expected to survive more than 3 months
- •5) Patient whose ECOG PS score is 2 and below
- •6) Patient who has measurable or evaluable lesion defined in RECIST v1.1
- •7) Patient with good hematological function
- •- Hemoglobin = 9.0 g/dL
- •- Absolute Neutrophil Count(ANC) =1,500/?
- •- Platlet = 100× 103/?
- •8) Patient with good renal function
- •- Creatinine = 1.5× ULN
- •- Creatinine clearance = 45 mL/min
- •9) Patient with good liver function
- •- ALT, AST = 2.5× ULN. ALT, AST = 5× ULN, for subject with liver metastasis
- •- Total bilirubin =1.5× ULN. Total bilirubin =3x ULN, for subject with liver metastasis or Gilbert Syndrome(unconjugated hyperbilirubinemia) in medical history,
- •10) A person who voluntarily decided to participate and consented in writing, after listening and understanding the detailed explanation about this clinical trial
Exclusion Criteria
- •1) Patient who had been diagnosed within the last 5 years with new primary cancer or others that effects non-small cell lung cancer.
- •2) In case of receiving immune suppressive drug within the last 2 weeks, or immune-checkpoint inhibitor, anti-CTLA-4 treatment within the last 6 weeks
- •3) In case of receiving antibiotics within the last 2 weeks
- •4) In case of taking Thiazide or Loop diuretic
- •5) In case of hypokalemia
- •6) In case of having interstitial lung disease in medical history
- •7) Patient with active autoimmune disease who required systemic therapy within the last 2 years
- •8) Patient with uncontrolled diabetes (uncontrolled with insulin or oral medication, fasting blood sugar)
- •9) Patient with uncontrolled hypertension (In case of systolic above 150mg or diastolic over 100mg, while taking blood pressure medicine)
- •10) Patient with heart defect (heart failure, angina, arrhythmia etc.)
- •11) Patient with genetic issues such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption and so on
- •12) Patient infected with active or untreated HIV, tuberculosis, Hepatitis B or Hepatitis C
- •13) Patient with significant hematologic disease(i.e., aneurysm requiring surgical operation or recent peripheral artery thrombosis) within 6 months before randomization
- •14) Patient with significant hematologic disease(i.e., aneurysm requiring surgical operation or recent peripheral artery thrombosis) within 6 months before randomization
- •15) Patient who has abdominal cavity, esophageal atresia or gastrointestinal duct perforation in medical history within 6 months before randomization
- •16) Patient who is yet unsolved with toxicity over CTCAE v5.0 level1 resulting from previous therapy when the trial therapy starts
- •17) A person who is seriously hypersensitive to ingredients in investigational drug.(rash, flare, hives, eczema, dermatitis, itchiness etc.)
- •18) Pregnant or lactating patient
- •19) In case of fertile women, patient who disagrees with use of effective contraception method for at least 5 months after the final administration of Atezolizumab, an immune-checkpoint inhibitor, during this clinical trial
- •20) Patient who took oriental medicine or functional food(ginseng etc.) within 4 weeks before the initial treatment of investigational drug and been decided by the investigator that such intake might effect the trial or subject’s safety
- •21) Patients who have participated in clinical trial within 4 weeks before the first administration of an investigational drug
- •22) Patient who’ve been decided unsuitable for this clinical trial by investigator including serious infectious disease or organ failure and others
Investigators
Similar Trials
Recruiting
Not Applicable
Efficacy and Safety of Bojungikgi-tang for Persistent Allergic Rhinitis: Study Protocol for a Randomized, Double-blind, Placebo-controlled, Phase II TrialKCT0006616Daejeon Korean Medicine Hospital of Daejeon University105
Not yet recruiting
Not Applicable
Efficacy and Safety of Yukmijihwang-tang in the Treatment of Cough-Variant Asthma: Study Protocol for a Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter TrialKCT0006994Daejeon Korean Medicine Hospital of Daejeon University60
Not yet recruiting
Not Applicable
Efficacy and Safety of Bojungikgi-tang for Anorexia in Patients with Colorectal Cancer after Curative Resection and Chemotherapy : A single-arm, Open label, Single cencer TrialDiseases of the digestive systemKCT0004785Pusan National University Korean Medicine Hospital20
Not yet recruiting
Not Applicable
Efficacy and Safety of Bojungikgi-tang for Anorexia in Lung Cancer Patients with treated with Chemotherapy: A Single-arm, Open label, Single center TrialKCT0004570Pusan National University Korean Medicine Hospital20
Recruiting
Not Applicable
Efficacy and safety of Yukmijihwang-tang in patients with type 2 diabetes who have microalbuminuria- a pilot studyEndocrine, nutritional and metabolic diseaseKCT0001853Daegu Catholic University Medical Center30