Predicting the effectiveness of PD-1 monoclonal antibody treatment for advanced esophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nanfang Hospital
  Guangzhou, China Recruiting

Study contacts

• Study coordinator: Shuai Chu
• Email: shine9533@smu.edu.cn
• Phone: 18665000310

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant therapy for resectable esophageal squamous cell carcinoma

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• Radiotherapy target-volume choices in locally advanced esophageal cancer during immunotherapy

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• Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer

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  Recruiting at 2 sites Phase 2 Shanghai Chest Hospital · Shanghai and 1 other locations · NCT07811752

• Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC

  This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.

  Recruiting Phase 2 First Affiliated Hospital Xi'an Jiaotong University · Xi'an, Shannxi · NCT07796113

• SKB500 combinations for esophageal squamous cell carcinoma

  This study tests SKB500 combined with other drugs to see if it is safe and shows early signs of activity in adults with unresectable or metastatic esophageal squamous cell carcinoma who have limited prior treatment.

  Recruiting at 24 sites Phase 2 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Changchun and 23 other locations · NCT07700667

• Neoadjuvant Cardonilizumab With Chemotherapy Before Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma

  This study tests whether adding cardonilizumab to preoperative chemotherapy (versus chemoradiotherapy) helps patients with locally advanced ESCC have a better chance at complete tumor removal and longer survival.

  Recruiting Phase 2 Tongji Hospital · Wuhan, Hubei · NCT07699185

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.