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An Open-label, Phase II Single Arm Trial of Stereotactic Body Radiotherapy for Oligoprogressive NSCLC After First Line Treatment With Immune Checkpoint Inhibitors

The Safety and Efficacy Evaluation of Stereotactic Body Radiotherapy for Oligoprogressive NSCLC After First Line Treatment with Immune Checkpoint Inhibitors

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059903
Enrollment
Unknown
Registered
2022-05-13
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

Lung cancer

Interventions

SBRT:SBRT

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years old; 2.ECOG PS 0-1; 3. Primary non-small cell lung cancer confirmed by pathology or cytology (AJCC stage IV in the eighth edition); 4. The disease is stable for more than 6 months after first-line immunotherapy or chemotherapy combined with immunotherapy; 5. After the first-line treatment, there was no progress, with = 5 progressive lesions and = 3 organs; 6. All proposed SBRT progressive lesions = 5cm, intracranial metastatic lesions = 3cm or volume = 30cc; 7. The researcher judged that all progressive lesions were feasible for SBRT, and there was no indication of palliative radiotherapy; 8. Palliative and symptomatic radiotherapy is allowed in the past, and the last radiotherapy time is more than 4 weeks; 9. The functional level of main organs meets the following standards; The blood routine examination standard should meet: WBC = 3.0 × 109/L or NC = 1.5 × 109/L PLT=100 × 109/L, Hb = 90g/L, biochemical inspection shall meet the following standards: TBIL, BUN and Cr = 1.5 × ULN ALTAST=2 × ULN 10. Estimated survival time = 3 months 11. Participate in clinical research voluntarily and sign the informed consent form. 12. The fertile men and women of childbearing age who participated in the study must agree to take effective contraceptive measures.

Exclusion criteria

Exclusion criteria: 1. The patient's previous medical history of malignant tumor (except cured non melanoma skin cancer, low-risk prostate cancer, T1/T2 glottic cancer, stage 0 or I breast cancer, non invasive bladder cancer, and cervical cancer in situ); 2. Patients with known EGFR (del19, L858R and T790M) mutations or ROS 1 or ALK gene rearrangements; 3. Histologically identified as mixed small cell lung cancer component; 4. Malignant pleural and ascites; 5. Brain metastasis requires intracranial decompression; 6. Symptoms of spinal cord compression; 7. Serious autoimmune diseases: inflammatory bowel disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Wegener's granulomatosis and related vasculitis; 8. Interstitial lung disease or clinically active pneumonia; 9. Have uncontrollable concomitant diseases within 6 months, including but not limited to symptomatic congestive heart failure, uncontrollable hypertension, unstable angina pectoris, arrhythmia, active peptic ulcer or hemorrhagic disease. 10. Pregnant or lactating women. 11. The researcher believes that the subject's complications or other conditions may affect the compliance with the protocol or may not be suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Progress free survival;

Secondary

MeasureTime frame
Overall survival;=Grade 3 toxicity;Time to new metastasis;

Contacts

Public ContactJinxiao Lai

Zhejiang Cancer Hospital

laixj@zjcc.org.cn+86 13819480002

Outcome results

None listed

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