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Chemotherapeutic agents exert significant immunomodulatory effects by influencing tumor-infiltrating immune cells. However, the sequence and combination of chemotherapy regimens differentially modulate immune cell dynamics, ultimately impacting treatment efficacy and patient survival. Glutathione, a critical bioactive molecule, demonstrates broad potential in tumor immunotherapy. Through mechanisms such as scavenging free radicals, modulating immune cell proliferation and differentiation, and regulating cytokine expression, glutathione achieves precise modulation of immune responses to enhance immune system functionality. To investigate whether glutathione can enhance the clinical efficacy of current chemo-immunotherapy regimens in non-small cell lung cancer (NSCLC), investigators conducted this clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 inhibitor plus chemotherapy arm | Placebo Comparator |
| |
| Glutathione combined with PD-1 inhibitor plus chemotherapy arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutathione | Drug | Glutathione is administered as an adjunct intervention to the PD-1 inhibitor plus chemotherapy regimen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | From randomization until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months." | |
| Overall Response Rate (ORR) | Proportion of patients achieving predefined tumor volume reduction with sustained duration, defined as those attaining a complete response (CR) or partial response (PR). | From the initiation of treatment until 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Immune Parameters | assess every 4 weeks via flow cytometry for peripheral CD8+ T-cell proportion and cytokine levels (e.g., IFN-γ, IL-2). | From baseline until 12 weeks post-treatment completion |
| QLQ-LC43 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Zhang | Contact | +86 15138928971 | yizhang@zzu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D005978 | Glutathione |
| D000082082 | Immune Checkpoint Inhibitors |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D045504 | Molecular Mechanisms of Pharmacological Action |
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| PD1 Inhibitor | Drug | e.g. pembrolizumab, camrelizumab, sintilimab, tislelizumab, toripalimab |
|
| Chemotherapy | Drug | Platinum-based doublet chemotherapy |
|
Quality of Life Questionnaire for Lung Cancer from the European Organization for Research and Treatment of Cancer (EORTC), assessed at baseline, the end of each treatment cycle (every 3 weeks), and at 12 and 24 weeks post-treatment using the Chinese version of the EORTC QLQ-LC43 questionnaire.
| From baseline until 24 weeks post-treatment completion |
| Overall survival | the time from randomization (or treatment initiation) to death from any cause, serving as the gold-standard endpoint for evaluating long-term therapeutic efficacy in oncology. | From randomization until death from any cause, assessed up to 60 months. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D013812 | Therapeutics |