Status:
RECRUITING
Influence of Radiotherapy and Chemotherapy in the Value of Peripheral Blood Lymphocyte Subsets Among Thoracic Cancer
Lead Sponsor:
Shanghai Cancer Hospital, China
Conditions:
NSCLC
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
This study is an observation, single center study to evaluate the alternations and prognostic value of peripheral blood lymphocyte (PBL) in patients diagnosed with thoracic cancers, including lung can...
Eligibility Criteria
Inclusion
- 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：
- 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;
- 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;
- Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min;
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04522687
Start Date
January 1 2012
End Date
December 1 2026
Last Update
August 21 2020
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032