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Search / Trial NCT05647330

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

Launched by HENAN CANCER HOSPITAL · Dec 3, 2022

Trial Information

Current as of June 23, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking to see how well a combination of two medications, hydroxychloroquine and gemcitabine, works for patients with advanced non-small cell lung cancer (NSCLC) who have already tried other treatments. The goal is to determine if this combination is effective and safe for patients whose cancer has not responded to previous therapies. The trial is currently not recruiting participants, but it aims to include adults aged 18 and older who have specific types of lung cancer that do not have certain genetic mutations.

To be eligible for the trial, patients must have measurable disease that can be tracked over time, and they should have had at least two previous treatment regimens. Additionally, patients need to meet certain health criteria to ensure their safety during the trial. This includes having a reasonable life expectancy and no significant ongoing health issues that could complicate their treatment. Participants can expect to take the medications as part of the study and will be closely monitored for their response and any side effects. It's important that patients understand the risks and benefits before deciding to join the trial, and they will need to provide informed consent to participate.

Gender

ALL

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) :
  • 1. Absolute neutrophil count ≥1.5×109/L;
  • 2. Platelets ≥80×109/L;
  • 3. Hemoglobin ≥9g/dL;
  • 4. Serum albumin ≥ 3G /dL;
  • 5. Total bilirubin ≤1.25×ULN;
  • 6. ALT and AST ≤2.5×ULN; If liver metastases were present, ALT and AST≤5×ULN;
  • 7. 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.

About Henan Cancer Hospital

Henan Cancer Hospital, a leading institution in oncology care and research, is dedicated to advancing cancer treatment through innovative clinical trials. With a commitment to improving patient outcomes, the hospital combines cutting-edge medical expertise with state-of-the-art facilities to conduct research that addresses critical gaps in cancer therapy. As a prominent sponsor of clinical trials, Henan Cancer Hospital focuses on developing novel therapeutic approaches and enhancing existing treatment protocols, fostering a collaborative environment that engages both patients and healthcare professionals in the pursuit of improved cancer care.

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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