Overview

Study of Thymosin α1 to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer

Status:
Active, not recruiting
Trial end date:
2023-09-01
Target enrollment:
0
Participant gender:
All
Summary
This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of acute pneumonia in non-small cell lung cancer with bulky tumor.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Treatments:
Thymalfasin
Criteria
Inclusion Criteria:

- Pathologic confirmation of NSCLC.

- Patients have measurable or evaluable lesions based on the Response Evaluation
Criteria in Solid Tumors (RECIST) criteria.

- Unresectable phase IIIA-IIIC lung cancer confirmed by PET/CT, CT or MRI.

- Whole lung V20>=35% when giving 60Gy which is the minimum dose of radical
irradiation.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

- Previously treated with chemotherapy or treatment-naive

- No previous chest radiotherapy, immunotherapy or biotherapy

- Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL

- Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60
ml/min

- Bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline
phosphatase ≤5 times UNL

- FEV1 >0.8 L

- CB6 within normal limits

- patients and their family signed the informed consents

Exclusion Criteria:

- Previous or recent another malignancy, except nonmelanoma skin cancer or cervical
cancer in situ

- Contraindication for chemotherapy

- Malignant pleural or pericardial effusion.

- Women in pregnancy, lactation period, or no pregnancy test 14 days before the first
dose

- Women who has the probability of pregnancy without contraception

- Tendency of hemorrhage

- In other clinical trials within 30 days

- Addicted in drugs or alcohol, AIDS patients

- Uncontrollable seizure or psychotic patients without self-control ability

- Severe allergy or idiosyncrasy

- Not suitable for this study judged by researchers