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出境医 / 临床实验 / Clinical Study of Propranolol Combined With Neoadjuvant Chemotherapy in Gastric Cancer

Clinical Study of Propranolol Combined With Neoadjuvant Chemotherapy in Gastric Cancer

Study Description
Brief Summary:
At the cellular and animal level, we found that propranolol can inhibit the proliferation and invasion of gastric cancer cells. Further, we want to explore the efficacy and safety of propranolol in the treatment of gastric cancer patients.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Propranolol Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Propranolol Combined With Neoadjuvant Chemotherapy in Stage III-IV Gastric Cancer: an Open-lable, Single-arm Study
Actual Study Start Date : November 20, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Prop+neochemo Drug: Propranolol
add propranolol in gastric cancer patients who need to receive preoperate chemotherapy

Outcome Measures
Primary Outcome Measures :
  1. ORR [ Time Frame: Preoperative assessment ]
    CR+PR


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must provide written informed consent.
  2. age 18 to 75;Confirmed as a primary gastric adenocarcinoma patient by imaging and histology or cytology;
  3. Patients with advanced gastrointestinal cancer who have received no prior chemotherapy or radiotherapy for malignant tumors;
  4. Patients with Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  5. Patients with a life expectancy of at least three months.;
  6. Organ function and hematopoietic function must meet the following requirements: hemoglobin (HGB) ≥ 90g / L; white blood cell count (WBC) ≥ 3 × 10 ^ 9 / L; absolute neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 / L Platelet count (PLT) ≥ 100 × 10 ^ 9 / L; total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase ( ALT)≤2.5×ULN; if abnormal liver function is due to tumor liver metastasis, AST or ALT≤5×ULN; serum creatinine (Cr)≤1.5×ULN; international normalized ratio (INR) or plasma prothrombin time ( PT) ≤ 1.5 × ULN.
  7. Systolic blood pressure 90-140mmHg, diastolic blood pressure 60-90mmHg, heart rate 60-100bpm.
  8. No previous cardiovascular and cerebrovascular diseases, and exclusion of atrioventricular block by 24-hour ambulatory electrocardiography;
  9. subjects must agree to take effective contraceptive measures between the subject and the partner after signing the informed consent, during the study period and within 5 months after the last dose.

Exclusion Criteria:

  1. There are clinical symptoms or diseases of the heart that are not well controlled, such as uncontrolled high blood pressure, unstable angina, or myocardial infarction within 6 months prior to enrollment, or poorly controlled arrhythmias (including QTc ( men ≥ 450ms , female ≥ 470ms, QTc interval calculated by Fridericia formula), cardiogenic shock, heart block (II-III degree atrioventricular block), severe or acute heart failure, sinus bradycardia, need continuous oxygen Treated severe respiratory diseases;
  2. Subjects with symptomatic autoimmune diseases [such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function; The tester has vitiligo or has completely relieved asthma in childhood, and can be included without any intervention after adulthood; asthma that requires bronchodilators for medical intervention cannot be included]
  3. Patients with other malignant tumors within 5 years prior to enrollment, in addition to appropriate treatment of cervical carcinoma in situ, cured skin basal cell carcinoma;
  4. Immunodeficiency, such as a patient with HIV infection or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
  5. Patients with active tuberculosis infection by medical history or CT examination, or a history of active tuberculosis infection within 1 year prior to enrollment, or patients with a history of active tuberculosis infection more than 1 year without formal treatment;
  6. Patients with tumor brain metastasis and bone marrow metastasis
  7. Patients who participated in other drug clinical studies within 4 weeks;
  8. Patients with history of hypersensitivity to any drugs in this study;
  9. Identified as neurological or psychiatric disorders, such as epilepsy, dementia, poor compliance;
  10. Alcohol abuse, drug abuse in the past year;
  11. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA (HBV DNA) > 10 ^ 3 copies / mL, or hepatitis C virus antibody positive; syphilis positive;
  12. Subjects had active infection or unexplained fever >38.5 degrees during Screening period before the first dose (according to the researcher, the subject can be enrolled due to fever generated by the tumor.);
  13. Clinical symptoms of ascites or pleural effusion, requiring therapeutic puncture or drainage;
  14. Female patients who are pregnant or lactating, or planning to become pregnant or lactating;
  15. Other patients who are considered to be unsuitable for this study by the investigator.
Contacts and Locations

Locations
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China, Hunan
Xiangya Hospital Central South University Recruiting
Changsha, Hunan, China, 410008
Contact: Yijing He, MD, PhD    +86-15874812612    yijinghe@gmail.com   
Sponsors and Collaborators
Yijing He
Xiangya Hospital of Central South University
Tracking Information
First Submitted Date  ICMJE June 29, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date November 26, 2019
Actual Study Start Date  ICMJE November 20, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2019)
ORR [ Time Frame: Preoperative assessment ]
CR+PR
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of Propranolol Combined With Neoadjuvant Chemotherapy in Gastric Cancer
Official Title  ICMJE Efficacy and Safety of Propranolol Combined With Neoadjuvant Chemotherapy in Stage III-IV Gastric Cancer: an Open-lable, Single-arm Study
Brief Summary At the cellular and animal level, we found that propranolol can inhibit the proliferation and invasion of gastric cancer cells. Further, we want to explore the efficacy and safety of propranolol in the treatment of gastric cancer patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE Drug: Propranolol
add propranolol in gastric cancer patients who need to receive preoperate chemotherapy
Study Arms  ICMJE Experimental: Prop+neochemo
Intervention: Drug: Propranolol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2019)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients must provide written informed consent.
  2. age 18 to 75;Confirmed as a primary gastric adenocarcinoma patient by imaging and histology or cytology;
  3. Patients with advanced gastrointestinal cancer who have received no prior chemotherapy or radiotherapy for malignant tumors;
  4. Patients with Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  5. Patients with a life expectancy of at least three months.;
  6. Organ function and hematopoietic function must meet the following requirements: hemoglobin (HGB) ≥ 90g / L; white blood cell count (WBC) ≥ 3 × 10 ^ 9 / L; absolute neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 / L Platelet count (PLT) ≥ 100 × 10 ^ 9 / L; total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase ( ALT)≤2.5×ULN; if abnormal liver function is due to tumor liver metastasis, AST or ALT≤5×ULN; serum creatinine (Cr)≤1.5×ULN; international normalized ratio (INR) or plasma prothrombin time ( PT) ≤ 1.5 × ULN.
  7. Systolic blood pressure 90-140mmHg, diastolic blood pressure 60-90mmHg, heart rate 60-100bpm.
  8. No previous cardiovascular and cerebrovascular diseases, and exclusion of atrioventricular block by 24-hour ambulatory electrocardiography;
  9. subjects must agree to take effective contraceptive measures between the subject and the partner after signing the informed consent, during the study period and within 5 months after the last dose.

Exclusion Criteria:

  1. There are clinical symptoms or diseases of the heart that are not well controlled, such as uncontrolled high blood pressure, unstable angina, or myocardial infarction within 6 months prior to enrollment, or poorly controlled arrhythmias (including QTc ( men ≥ 450ms , female ≥ 470ms, QTc interval calculated by Fridericia formula), cardiogenic shock, heart block (II-III degree atrioventricular block), severe or acute heart failure, sinus bradycardia, need continuous oxygen Treated severe respiratory diseases;
  2. Subjects with symptomatic autoimmune diseases [such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function; The tester has vitiligo or has completely relieved asthma in childhood, and can be included without any intervention after adulthood; asthma that requires bronchodilators for medical intervention cannot be included]
  3. Patients with other malignant tumors within 5 years prior to enrollment, in addition to appropriate treatment of cervical carcinoma in situ, cured skin basal cell carcinoma;
  4. Immunodeficiency, such as a patient with HIV infection or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
  5. Patients with active tuberculosis infection by medical history or CT examination, or a history of active tuberculosis infection within 1 year prior to enrollment, or patients with a history of active tuberculosis infection more than 1 year without formal treatment;
  6. Patients with tumor brain metastasis and bone marrow metastasis
  7. Patients who participated in other drug clinical studies within 4 weeks;
  8. Patients with history of hypersensitivity to any drugs in this study;
  9. Identified as neurological or psychiatric disorders, such as epilepsy, dementia, poor compliance;
  10. Alcohol abuse, drug abuse in the past year;
  11. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA (HBV DNA) > 10 ^ 3 copies / mL, or hepatitis C virus antibody positive; syphilis positive;
  12. Subjects had active infection or unexplained fever >38.5 degrees during Screening period before the first dose (according to the researcher, the subject can be enrolled due to fever generated by the tumor.);
  13. Clinical symptoms of ascites or pleural effusion, requiring therapeutic puncture or drainage;
  14. Female patients who are pregnant or lactating, or planning to become pregnant or lactating;
  15. Other patients who are considered to be unsuitable for this study by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04005365
Other Study ID Numbers  ICMJE 2019/prop/GC/CSU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yijing He, Central South University
Study Sponsor  ICMJE Yijing He
Collaborators  ICMJE Xiangya Hospital of Central South University
Investigators  ICMJE Not Provided
PRS Account Central South University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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