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Clinical Study of PD-1 Inhibitors and Chemotherapy Combined With Iodine-125 Particle Therapy for Driver Negative Non-Small Cell Lung Cancer

Clinical Study of PD-1 Inhibitors and Chemotherapy Combined With Iodine-125 Particle Therapy for Driver Negative Non-Small Cell Lung Cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061344
Enrollment
Unknown
Registered
2022-06-21
Start date
2022-06-08
Completion date
Unknown
Last updated
2023-04-03

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:Iodine 125 particle

Sponsors

Bishan Hospital Affiliated to Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age = 18 years old; 2. Patients with stage IV NSCLC confirmed by histopathology (according to the definition of AJCC 8th Edition); 3. NSCLC patients who have previously failed to receive first-line or more systematic treatment; 4. ECOG score 0-2 points; 5. Estimated survival period = 3 months; 6. According to recist 1.1 standard, there is at least one measurable lesion; 7. Previously, no EGFR sensitive mutation and alk, ros1 gene fusion mutation were detected based on tissue examination, and the driver gene was negative; 8.PD-L1 expression was not limited; 9. Be able to provide written informed consent (ICF) and understand and agree to comply with the study requirements and evaluation schedule;

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women; 2. Previous serious adverse drug reactions; 3. Uncontrollable basic medical diseases such as hypertension, diabetes, cerebral infarction and coronary heart disease; 4. Mental illness and inability to cooperate; 5. Combined with autoimmune diseases; 6. Advanced cachexia; 7. Incomplete medical history; 8. Patients with brain metastasis with headache, vomiting, blurred vision, hemiplegia or hemiplegia, unclear language and other symptoms; 9. Severe infection occurred within 4 weeks before enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia; 10. Severe chronic or active infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic treatment within 14 days before enrollment; 11. Have a history of interstitial lung disease, non-infectious pneumonia or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc; 12. Untreated patients with chronic hepatitis B, HBV carriers with hepatitis B virus (HBV) DNA = 500 iu/ml, or patients with active hepatitis C virus (HCV) should be excluded. Note: inactive hepatitis B, HBsAg carriers, treated and stable hepatitis B carriers (HBV DNA < 500 iu/ml), and cured hepatitis C patients can be included in the group; 13. Known history of HIV infection; 14. There were contraindications of iodine 125 particle interventional therapy, such as obvious dysfunction of important organs and tumor in ulcer deterioration stage; 15. Received any other trial drug treatment or participated in other clinical trials within 28 days. 16. Active pia mater disease caused by metastatic NSCLC, or uncontrolled and untreated brain metastasis 17. The toxicity caused by previous anti-cancer treatment has not been restored to the baseline level or stable, which is not a possible safety risk, except for hair loss, rash, pigmentation or specific laboratory abnormalities.

Design outcomes

Primary

MeasureTime frame
progression free survival;

Countries

China

Contacts

Public ContactLan Sun
sunlan6203@163.com+86 15223458738

Outcome results

None listed

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