Influence of Radiotherapy and Chemotherapy in the Value of Peripheral Blood Lymphocyte Subsets Among Thoracic Cancer

Launched by SHANGHAI CANCER HOSPITAL, CHINA · Aug 19, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how radiotherapy (a type of cancer treatment using high-energy rays) and chemotherapy (medications that kill cancer cells) affect certain white blood cells called lymphocytes in patients with thoracic cancers, which include lung cancer, esophageal cancer, and thymic cancer. Researchers want to understand how changes in these lymphocytes can help predict patient outcomes after treatment.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of one of the targeted cancers. You should also be in relatively good health, meaning your organs are functioning well, and you have a life expectancy of more than three months. Participants will need to agree to provide fresh tumor samples for research and use contraception if they are of childbearing age. The study is currently recruiting patients, and if you join, you can expect to undergo treatment while helping researchers learn more about how these therapies affect your immune system.

Gender

ALL

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.