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Hydroxychloroquine Combined With Gemcitabine in the Treatment of Advanced Non-small Cell Lung Cancer

Primary Purpose

Hydroxychloroquine, Gemcitabine, Lung Neoplasms

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hydroxychloroquine Combined With Gemcitabine
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hydroxychloroquine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have histologically or cytologically proven advanced lung squamous cell carcinoma or lung adenocarcinoma with negative EGFR and ALK gene mutations. Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, meaning that at least one lesion can be accurately measured by conventional techniques of CT or MRI. It is acceptable for patients who have received radiotherapy. It must be at least 4 months after radiotherapy, and all signs of toxicity must abate. The patient must be 18 years of age or above. The ECOG performance status of patients must be 0-1. Patients should not become pregnant or breastfeed because chemotherapy is considered to pose significant risks to the fetus/baby. The patient must have a life expectancy of more than three months. Patients must be able to understand and willing to sign written informed consent. Previously received systematic treatment with 2 regimens; Treatment with hydroxychloroquine sulfate tablets plus gemcitabine is required to be initiated within 28 days after informed consent; The function of vital organs should meet the following requirements as far as possible (if laboratory test values do not meet the following criteria, they can also be included in the registration after comprehensive evaluation by researchers) : Absolute neutrophil count ≥1.5×109/L; Platelets ≥80×109/L; Hemoglobin ≥9g/dL; Serum albumin ≥ 3G /dL; Total bilirubin ≤1.25×ULN; ALT and AST ≤2.5×ULN; If liver metastases were present, ALT and AST≤5×ULN; serum creatinine ≤1.25×ULN or creatinine clearance ≥50mL/min. Exclusion Criteria: Patients with rapid progression after 1 or 2 cycles in first-line and second-line regimens. Persons with known allergies or metabolic disorders to any drug in the treatment regimen. Patients who had previously received hydroxychloroquine. Patients with known G6PD deficiency, severe psoriasis, porphyria, macular degeneration, or severe diabetic retinopathy were ineligible because of the potential for greater hydroxychloroquine toxicity. Symptomatic central nervous metastasis. Patients with asymptomatic brain metastases or stable brain metastases after treatment were eligible to participate in the study if they met all the following criteria: measurable lesions outside the central nervous system; No mesencephalon, pons, cerebellum, meninges, medulla oblongata or spinal cord metastases; Maintain clinical stability for at least 2 weeks. A history of psychotropic drug abuse, alcoholism or drug abuse; In the 6 months prior to study entry, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, New York Heart Association (NYHA) grade 2 or higher cardiac dysfunction, and poorly controlled arrhythmias (including QT c F interval men & GT; 450 m s, female & GT; 470 ms, QT cF interval calculated by Fridericia formula), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; Acute or chronic active hepatitis B (HBsAg positive and HBV DNA & g t; 1*103/ml) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA & g t; 15 iu/ml); Active pulmonary tuberculosis; Other factors that may affect patient safety or compliance as determined by the investigator. If there is a serious illness (including mental illness) that requires concomitant treatment, serious laboratory abnormalities, or other family or social factors. Patients deemed inappropriate for enrollment by the investigator.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hydroxychloroquine combined with gemcitabine

    Arm Description

    Hydroxychloroquine sulfate tablets: twice a day, each time (600mg). Continuous oral administration. Until the disease progresses or becomes intolerable. gemcitabine was administered intravenously at a dose of 1000mg/m2 for 30min,d1, 8, and every 3 weeks (21 days) until disease progression or intolerable toxicity, with a maximum duration of 2 years.

    Outcomes

    Primary Outcome Measures

    Objective response rate(ORR)
    The proportion of patients whose tumor volume reduction reaches the predetermined value and can maintain the minimum time limit is the sum of the proportion of complete and partial remission.

    Secondary Outcome Measures

    Disease control rate(DCR)
    The percentage of patients with PR + Cr and SD after treatment in the number of evaluable cases, and the RECIST standard is at least 4 weeks
    Progression-free survival(PFS)
    The time between initiation of the study drug and the first recorded date of disease progression (PD) or death, depending on which occurred first. If no disease progression is observed, the cutoff date should be the date of the last tumor measurement.
    Overall survival(OS)
    The time from the beginning of treatment to (for any reason) death. The last follow-up time is usually calculated as the time of death for the subjects who have lost the visit before death

    Full Information

    First Posted
    September 15, 2022
    Last Updated
    December 3, 2022
    Sponsor
    Henan Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05647330
    Brief Title
    Hydroxychloroquine Combined With Gemcitabine in the Treatment of Advanced Non-small Cell Lung Cancer
    Official Title
    Phase II Clinical Study of Hydroxychloroquine Combined With Gemcitabine in the Treatment of Advanced Non-small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 15, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    October 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Henan Cancer Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To evaluate the efficacy and safety of hydroxychloroquine (600mgBID) combined with gemcitabine (1000mg/m2,d1,8) in the third-line and above treatment of advanced NSCLC.
    Detailed Description
    This study is a single-arm, open phase II prospective cohort study to evaluate the efficacy and safety of hydroxychloroquine (600mgBID) combined with gemcitabine in the treatment of advanced NSCLC patients with third-line and above treatment. After signing informed consent, the subjects were screened and eligible for inclusion in this study. All enrolled subjects will be treated with (hydroxychloroquine 600mgBID) plus gemcitabine, and each patient will continue to receive the study drug until the end of the treatment cycle. The efficacy index and safety index were observed during the treatment. Hydroxychloroquine sulfate tablets: twice a day, each time (600mg). Continuous oral administration. Until the disease progresses or becomes intolerable. gemcitabine was administered intravenously at a dose of 1000mg/m2 for 30min,d1, 8, and every 3 weeks (21 days) until disease progression or intolerable toxicity, with a maximum duration of 2 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hydroxychloroquine, Gemcitabine, Lung Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    55 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hydroxychloroquine combined with gemcitabine
    Arm Type
    Experimental
    Arm Description
    Hydroxychloroquine sulfate tablets: twice a day, each time (600mg). Continuous oral administration. Until the disease progresses or becomes intolerable. gemcitabine was administered intravenously at a dose of 1000mg/m2 for 30min,d1, 8, and every 3 weeks (21 days) until disease progression or intolerable toxicity, with a maximum duration of 2 years.
    Intervention Type
    Drug
    Intervention Name(s)
    Hydroxychloroquine Combined With Gemcitabine
    Other Intervention Name(s)
    chloroquine
    Intervention Description
    Hydroxychloroquine combined with chemotherapy
    Primary Outcome Measure Information:
    Title
    Objective response rate(ORR)
    Description
    The proportion of patients whose tumor volume reduction reaches the predetermined value and can maintain the minimum time limit is the sum of the proportion of complete and partial remission.
    Time Frame
    1years
    Secondary Outcome Measure Information:
    Title
    Disease control rate(DCR)
    Description
    The percentage of patients with PR + Cr and SD after treatment in the number of evaluable cases, and the RECIST standard is at least 4 weeks
    Time Frame
    2 years
    Title
    Progression-free survival(PFS)
    Description
    The time between initiation of the study drug and the first recorded date of disease progression (PD) or death, depending on which occurred first. If no disease progression is observed, the cutoff date should be the date of the last tumor measurement.
    Time Frame
    2 years
    Title
    Overall survival(OS)
    Description
    The time from the beginning of treatment to (for any reason) death. The last follow-up time is usually calculated as the time of death for the subjects who have lost the visit before death
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must have histologically or cytologically proven advanced lung squamous cell carcinoma or lung adenocarcinoma with negative EGFR and ALK gene mutations. Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, meaning that at least one lesion can be accurately measured by conventional techniques of CT or MRI. It is acceptable for patients who have received radiotherapy. It must be at least 4 months after radiotherapy, and all signs of toxicity must abate. The patient must be 18 years of age or above. The ECOG performance status of patients must be 0-1. Patients should not become pregnant or breastfeed because chemotherapy is considered to pose significant risks to the fetus/baby. The patient must have a life expectancy of more than three months. Patients must be able to understand and willing to sign written informed consent. Previously received systematic treatment with 2 regimens; Treatment with hydroxychloroquine sulfate tablets plus gemcitabine is required to be initiated within 28 days after informed consent; The function of vital organs should meet the following requirements as far as possible (if laboratory test values do not meet the following criteria, they can also be included in the registration after comprehensive evaluation by researchers) : Absolute neutrophil count ≥1.5×109/L; Platelets ≥80×109/L; Hemoglobin ≥9g/dL; Serum albumin ≥ 3G /dL; Total bilirubin ≤1.25×ULN; ALT and AST ≤2.5×ULN; If liver metastases were present, ALT and AST≤5×ULN; serum creatinine ≤1.25×ULN or creatinine clearance ≥50mL/min. Exclusion Criteria: Patients with rapid progression after 1 or 2 cycles in first-line and second-line regimens. Persons with known allergies or metabolic disorders to any drug in the treatment regimen. Patients who had previously received hydroxychloroquine. Patients with known G6PD deficiency, severe psoriasis, porphyria, macular degeneration, or severe diabetic retinopathy were ineligible because of the potential for greater hydroxychloroquine toxicity. Symptomatic central nervous metastasis. Patients with asymptomatic brain metastases or stable brain metastases after treatment were eligible to participate in the study if they met all the following criteria: measurable lesions outside the central nervous system; No mesencephalon, pons, cerebellum, meninges, medulla oblongata or spinal cord metastases; Maintain clinical stability for at least 2 weeks. A history of psychotropic drug abuse, alcoholism or drug abuse; In the 6 months prior to study entry, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, New York Heart Association (NYHA) grade 2 or higher cardiac dysfunction, and poorly controlled arrhythmias (including QT c F interval men & GT; 450 m s, female & GT; 470 ms, QT cF interval calculated by Fridericia formula), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; Acute or chronic active hepatitis B (HBsAg positive and HBV DNA & g t; 1*103/ml) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA & g t; 15 iu/ml); Active pulmonary tuberculosis; Other factors that may affect patient safety or compliance as determined by the investigator. If there is a serious illness (including mental illness) that requires concomitant treatment, serious laboratory abnormalities, or other family or social factors. Patients deemed inappropriate for enrollment by the investigator.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Hydroxychloroquine Combined With Gemcitabine in the Treatment of Advanced Non-small Cell Lung Cancer

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