Evaluating blood lymphocyte changes in thoracic cancer patients undergoing treatment

Observation of the Impact of Radiotherapy With or Without Chemotherapy in the Value of Peripheral Blood Lymphocyte Subsets for Patients With Thoracic Cancer

This study is trying to see how treatment affects blood cells in patients with lung cancer, esophageal cancer, or thymic tumors to understand their health better.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Cancer Hospital, China (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT04522687 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the alterations and prognostic significance of peripheral blood lymphocyte subsets in patients diagnosed with thoracic cancers, specifically non-small cell lung cancer, esophageal squamous cell carcinoma, and thymic epithelial tumors. Participants will be monitored for changes in their lymphocyte profiles after receiving radiotherapy, with or without chemotherapy. The study will involve collecting fresh tumor biopsies and evaluating the patients' overall health and organ function prior to enrollment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed thoracic cancers and adequate organ function.

Not a fit: Patients with a life expectancy of less than three months or those requiring palliative radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the immune response of thoracic cancer patients, potentially guiding more personalized treatment approaches.

How similar studies have performed: While similar studies have explored lymphocyte profiles in cancer treatment, this specific approach focusing on thoracic cancers is relatively novel.

Eligibility criteria

Inclusion Criteria:

Age at least 18 years. ECOG PS 0-1. Pathologically confirmed NSCLC, esophageal squamous cell carcinoma or thymic epithelial tumor.

Life expectancy of more than 3 months. Patients with no indications for palliative radiotherapy in the opinion of the investigator.

Patients with a prior history of surgery are eligible if they have recovered adequately from the toxicity and/or complications of surgery.

Signed informed consent for the use of fresh tumor biopsies before and during the treatment.

Women of childbearing age and men must agree to use effective contraception during the trial.

Adequate organ function within 1 week prior to the enrollment：

1. Adequate bone marrow function: hemoglobin ≥80g/L, white blood cell (WBC) count ≥ 4.0 \* 10 \^ 9/L or neutrophil count ≥ 1.5 \* 10 \^ 9/L, and platelet count ≥ 100 \* 10 \^ 9/L;
2. Adequate hepatic function: total bilirubin \< 1.5 x upper limit of normal (ULN). Note: If total bilirubin is \> 1.5 x ULN, direct bilirubin must ≤ ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 ULN;
3. Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min;

Exclusion Criteria:

Pregnant or lactating women. History of any other malignancy. Patients in whom palliative radiotherapy is indicated in the opinion of the investigator.

Active infection, congestive heart failure, myocardial infarction within the 6 months prior to enrollment, unstable angina pectoris or cardiac arrhythmia.

Patients who have received tumor vaccine; or administration of live, attenuated vaccine within 4 weeks before the start of treatment.

Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Conditions: NSCLC, Esophageal Squamous Cell Carcinoma, Thymic Epithelial Tumor