HydroxychloroquinePhase 2NCT05647330
Hydroxychloroquine Combined With Gemcitabine in the Treatment of Advanced Non-small Cell Lung Cancer
A Phase 2 study testing Hydroxychloroquine Combined With Gemcitabine in people with Hydroxychloroquine and Gemcitabine, run by Henan Cancer Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hydroxychloroquine, Gemcitabine, Lung Neoplasms
- What is being tested?
- Hydroxychloroquine Combined With Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2022to 1 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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 this study
Official title: Phase II Clinical Study of Hydroxychloroquine Combined With Gemcitabine in the Treatment of Advanced Non-small Cell Lung Cancer
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.
Read the 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.
- Conditions
- Hydroxychloroquine, Gemcitabine, Lung Neoplasms
- Being tested
- Hydroxychloroquine Combined With Gemcitabine
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine Combined With GemcitabineDrug
Also called chloroquine
Hydroxychloroquine combined with chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine combined with gemcitabine | Experimental | 1. Hydroxychloroquine sulfate tablets: twice a day, each time (600mg). Continuous oral administration. Until the disease progresses or becomes intolerable.
2. 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. Receives: Drug: Hydroxychloroquine Combined With Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1years
Secondary outcomes (3)
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
Measured: 2 years
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.
Measured: 2 years
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start15 Dec 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydroxychloroquineStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647330
- Sponsor's protocol ID
- 2022213
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Hydroxychloroquine Combined With Gemcitabine in the Treatment of Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05647330
- Acronym / sponsor ID
- 2022213
- Conditions
- Hydroxychloroquine, Gemcitabine, Lung Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine combined with gemcitabine | Experimental | Drug: Hydroxychloroquine Combined With Gemcitabine1. Hydroxychloroquine sulfate tablets: twice a day, each time (600mg). Continuous oral administration. Until the disease progresses or becomes intolerable. 2. 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine Combined With GemcitabineAlso: chloroquineHydroxychloroquine combined with chemotherapy | Drug | Hydroxychloroquine combined with gemcitabine |
Primary outcome
Objective response rate(ORR)
Time frame: 1years
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.
3 secondary outcomes
Disease control rate(DCR)
Time frame: 2 years
Progression-free survival(PFS)
Time frame: 2 years
Overall survival(OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine Combined With Gemcitabine in people with Hydroxychloroquine and Gemcitabine, run by Henan Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate(ORR) (time frame: 1years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.