Predicting the effectiveness of PD-1 monoclonal antibody treatment for advanced esophageal cancer
Construction and Application of Immune Indicator Model for Predicting Efficacy of PD-1 Monoclonal Antibody in the Treatment of Advanced Esophageal Cancer
This study is trying to see if changes in immune cells can help predict how well PD-1 antibody treatment works for people with advanced esophageal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, prednisone |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT05392413 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enroll 200 patients with advanced esophageal squamous cell carcinoma who are receiving PD-1 monoclonal antibody treatment. It will analyze changes in peripheral blood immune cells before and after treatment to develop a machine learning model that predicts the efficacy of the therapy. The study will also explore the relationship between the immune indicator model and PD-L1 expression levels in tumor tissue. Ultimately, the goal is to enhance treatment selection and improve outcomes for patients undergoing PD-1 monoclonal antibody therapy.
Who should consider this trial
Good fit: Ideal candidates include patients with metastatic advanced esophageal squamous cell carcinoma who are about to start PD-1 monoclonal antibody treatment.
Not a fit: Patients with early-stage esophageal cancer or those not eligible for PD-1 monoclonal antibody therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for predicting which patients will benefit most from PD-1 monoclonal antibody therapy.
How similar studies have performed: While predictive models in oncology are being explored, this specific approach using peripheral blood immune cells for PD-1 therapy in esophageal cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with metastatic advanced esophageal squamous cell carcinoma (stage IV) confirmed by histology or cytology who are ready to receive PD-1 monoclonal antibody combined with TP chemotherapy regimen. * Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 2. * Have measurable lesions. * Expected survival \> 3 months. * Subjects who have received anti-tumor therapy in the past should be enrolled after the toxicity of the previous treatment has returned to the baseline level (except for residual hair loss effects) or CTCAE v4.03 scale score ≤ 1. * Female or male subjects of reproductive age and their partners should agree to use effective contraception from the time of signing the ICF until 6 months after the last dose of study drug. * Absolute neutrophil count (ANC) ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥9 g/dL. Liver: Bilirubin ≤1.5 times the upper limit of normal, alkaline phosphatase (AP) , Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 times the upper limit of normal (AP, AST, ALT ≤5 times the upper limit of normal are allowed if there is liver metastases) Renal: Calculated creatinine clearance ≥45 mL/min. Exclusion Criteria: * Have active, or have had an autoimmune disease that is likely to recur (eg, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.) or at risk (e.g., organ transplant recipients requiring immunosuppressive therapy). * Subjects who need to receive glucocorticoid (prednisone \> 10 mg/day or equivalent dose of other similar drugs) or other immunosuppressive therapy due to certain conditions within 14 days prior to study drug administration. * Major surgery, or radical radiation therapy, or palliative radiation therapy within the previous 14 days, or radiopharmaceuticals (strontium, samarium, etc.) within 56 days before starting study treatment. * Received systemic anti-tumor therapy, including immunotherapy, biological therapy (tumor vaccines, cytokines, or growth factors to control cancer), etc. 14 days before starting study treatment. * Have suffered from interstitial lung disease, chemical pneumonia, hypersensitivity pneumonitis, connective tissue disease pneumonia, pulmonary fibrosis, acute lung disease, etc. (except for local interstitial pneumonia induced by radiotherapy), or uncontrolled systemic disease, including diabetes and hypertension. * Patients with human immunodeficiency virus (HIV) infection. * patients with active pulmonary tuberculosis. * Any active infection requiring systemic therapy by intravenous infusion within 2 weeks prior to the first dose of study drug. * People who have received a solid organ transplant. * Patients who have received any antibody/drug (including anti-programmed death-1 (PD-1), PD-L1, etc.) targeting T-cell co-regulatory proteins (immune checkpoints).
Where this trial is running
Guangzhou
- Nanfang Hospital — Guangzhou, China (Recruiting)
Study contacts
- Study coordinator: Shuai Chu
- Email: shine9533@smu.edu.cn
- Phone: 18665000310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.