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Prospective, multi-center, single-arm clinical study of CalliSpheres drug-loaded embolization microspheres in the treatment of locally advanced non-small cell lung cancer after chemotherapy failure

Prospective, multi-center, single-arm clinical study of CalliSpheres drug-loaded embolization microspheres in the treatment of locally advanced non-small cell lung cancer after chemotherapy failure

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025295
Enrollment
Unknown
Registered
2019-08-21
Start date
2019-09-09
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

Non-small cell carcinoma

Interventions

Case series:CalliSpheres can be loaded with drug-loading microspheres

Sponsors

The First People's Hospital of Chenzhou
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: If the patient meets all of the following criteria, the patient may be enrolled in the study: (1) Aged >= 18 years, gender is not limited; (2) Pathological and/or cytological examination confirmed by fiberoptic bronchoscopy or CT-guided biopsy as NSCLC, TNM stage III-IVa, genetic test (EGFR, ALK gene test) negative or rejected / no economic ability to use target To the drug, no indication of surgery or rejection of surgery; (3) Progress after first-line chemotherapy and no head and other distant metastasis; (4) The expected survival period is greater than 3 months; (5) The US Eastern Oncology Cooperative Group (ECOG) has a physical status (PS) score of <= 2 points; (6) The pregnancy test for women of childbearing age must be negative; or male and female patients should agree to use effective contraception during the treatment period and for the following year; (7) The patient signed an informed consent form that agreed to participate in the trial study, which was able to follow up and was well compliant.

Exclusion criteria

Exclusion criteria: (1) Can perform surgical tumor resection; (2) Poor coagulation function INR>1.5, or anticoagulant therapy or known bleeding disorder; (3) Unstable coronary heart disease or recent myocardial infarction (within one year); (4) Recent infections require antibiotic treatment; (5) DSA shows that the tumor blood supply artery contains the anterior spinal artery and/or esophageal artery and cannot be avoided; the bronchial artery is too slender and the intubation is unsuccessful; the arteriovenous fistula is expected to be unable to embolize the microsphere; (6) Complications or social environment that can cause the subject to fail to follow the research plan or even endanger the safety of the patient; (7) With other primary tumors. The investigator judged that the subject had other factors that might cause the study to be terminated midway. For example, other serious diseases (including mental illness) require combined treatment, serious laboratory abnormalities, and family or society factor.

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
PFS;1 year, 2 year survival rate;Improvement in lung function;Improvement in living conditions;Safety evaluation;

Countries

China

Contacts

Public ContactHaixue Dai

The First People's Hospital of Chenzhou

daihaixue@126.com+86 17721416526

Outcome results

None listed

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