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The effect of radiotherapy with different dose fractionation in NSCLC patients on adverse events and anti-tumor immunological activity of peripheral T lymphocyte

The effect of radiotherapy with different dose fractionation in NSCLC patients on adverse events and anti-tumor immunological activity of peripheral T lymphocyte

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037735
Enrollment
Unknown
Registered
2020-08-31
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

control group: conventional radiotherapy GTV+CTV
treatment group 1:conventional radiotherapy GTV
treatment group 2:hypofractionated radiotherapy ( GTV: 3-4Gy×13-19F)
treatment group 3:hypofractionated radiotherapy ( GTV: 5-10Gy×5-12F)

Sponsors

Department of oncology Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. histologically proven non-small cell lung cancer without driver gene mutation; 2. AJCC stage IIIA-IIIC; 3. Adequate hematologic and end organ function, defined by the following laboratory results obtained within 7 days prior to randomization: Hemoglobin >= 100g/L, ANC >= 1.5*10^9/L without granulocyte colony-stimulating factor support, Platelet count >= 100*10^9/L; Serum bilirubin = 60ml/min, urea nitrogen = 70; 6. Male or female aged >= 18 years; 7. No autoimmune disease; 8. Comply with radiotherapy; 9. Signed Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. Prior radiotherapy for NSCLC; 2. Prior or current usage of CPI; 3. Malignancies other than NSCLC within 5 years prior to randomization; 4. Active infections; 5. History of congenital or acquired immunodeficiency; 6. History of autoimmune diseases; 7. History of mental disorders or mental illness can not cooperate with treatment; 8. History of serious heart, liver, lung, kidney, digestive and urinary system diseases.

Design outcomes

Primary

MeasureTime frame
Acute and late radiotherapy-related toxicity;Local regional failure free survival, LRFFS;

Secondary

MeasureTime frame
Progression-Free-Survival, PFS;Overall survival, OS;

Countries

China

Contacts

Public ContactGuanghui Li

Department of Oncology Second Affiliated Hospital of Army Medical University

am831103@163.com+86 13996181950

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026