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The Efficacy and Safety of Stereotactic Radiotherapy Combined with Puterizumab in Non Small Cell Lung Cancer with Intrapulmonary Metastasis:A Phase II Prospective Single Arm Clinical Study

The Efficacy and Safety of Stereotactic Radiotherapy Combined with Puterizumab in Non Small Cell Lung Cancer with Intrapulmonary Metastasis:A Phase II Prospective Single Arm Clinical Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085132
Enrollment
Unknown
Registered
2024-05-31
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-06-03

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

experimental group:Stereotactic Radiotherapy

Sponsors

Sir Runrun Shaw Hospital Affiliated to Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1: age=18 2: Non small cell lung cancer patients who have experienced pulmonary metastasis after PD-1 immunotherapy in the past 3: Voluntarily participate in this study and sign an informed consent form 4: The presence of evaluable size and number of pulmonary metastases on chest CT 5: There are indications for lung puncture biopsy 6: General physical condition (ECOG) 0-1 7: The laboratory test meets the following standards: white blood cell count>3.5 × 109/L, absolute value of neutrophils>1.8 × 109/L, platelet count = 75 × 109/L, hemoglobin = 100g/L; NR = 1.5, and APTT = 1.5 times the upper limit of normal value or partial prothrombin time (PT) = 1.5 times the upper limit of normal value; Total bilirubin = 1.25 times the upper limit of normal value; ALT and AST50mL/min or blood creatinine<1.5 times the upper limit of normal value

Exclusion criteria

Exclusion criteria: 1:   Unable to tolerate or refuse further immunotherapy 2:   Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiteracy, etc

Design outcomes

Primary

MeasureTime frame
Tumor Response Rate;

Secondary

MeasureTime frame
Minor Residual Lesions;progression-free survival;overall survival;RTOG acute radiation injury grading;Quality of life scores;Lymphocyte subpopulation analysis;

Countries

China

Contacts

Public ContactXiaonan Sun

Sir Runrun Shaw Hospital Affiliated to Zhejiang University School of Medicine

sunxiaonan@zju.edu.cn+86 136 0661 8387

Outcome results

None listed

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