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Objective to evaluate a prospective, single arm, single center clinical study of vinorelbine loaded callispheres microspheres in the treatment of stage III - IV non-small cell lung cancer with obstructive atelectasis

Objective to evaluate a prospective, single arm, single center clinical study of vinorelbine loaded callispheres microspheres in the treatment of stage III - IV non-small cell lung cancer with obstructive atelectasis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042535
Enrollment
Unknown
Registered
2021-01-23
Start date
2021-01-23
Completion date
Unknown
Last updated
2021-05-03

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

Conditions

Lung cancer

Interventions

single arm:CalliSpheres drug-eluting beads bronchial arterial chemoembolization

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients with NSCLC confirmed by histology or cytology had obstructive atelectasis (at least one segment of atelectasis) by imaging examination; 2. Patients with at least one measurable lesion (evaluated according to recist1.1) should have TNM stage III or above, and the stage should be based on the International Union against cancer (UICC) staging standard 8th Edition; 3. Patients with no operation indication and failure of conventional treatment such as radiotherapy, chemotherapy, targeting and immunization; 4. Patients aged 18-85 5. Laboratory examination showed that there was no significant abnormality in the main functional organs (1) The standard of blood routine examination should meet the following standards WBC=3.0 × 109/L PLT=100 × 109/L HGB=10.0g/L NEUT#=1.5 × 109/L (2) Biochemical tests should meet the following standards: Liver function: 1 ALT?AST= 1.5 ULN; BIL=1.5 ULN; Renal function: 1 Cr=1.5 ULN BUN:2.86-7.14mmol/L 6. Patients with ECoG = 2; 7. Patients whose expected survival time is more than or equal to 3 months; 8. The subjects volunteered to join the study and signed informed consent, with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with other malignant tumors; 2. Patients with uncontrolled distal metastasis; 3. Patients with a history of major diseases involving the heart, kidney, liver, bone marrow or central nervous system, 4. Patients with uncontrollable diabetes, hypertension or ischemic heart disease; 5. Pregnant or lactating women; 6. Patients whose clinical conditions were not suitable for d-bace (contraindication of arterial puncture) were judged by researchers; 7. Patients with obvious arteriovenous fistula; 8. Those patients whose CTA showed no obvious blood supply artery at the end of tumor circulation before operation; 9. Patients allergic to vinorelbine and iodine contrast media; 10. According to the judgment of the researchers, there are patients with accompanying diseases that seriously endanger the safety of patients or affect the completion of the study; 11. Patients who are currently participating in or have participated in other clinical trials within 4 weeks before surgery; 12. Patients with mental illness or history of psychotropic substance abuse.

Design outcomes

Primary

MeasureTime frame
ORR;

Countries

China

Contacts

Public ContactSen Jiang

Shanghai Pulmonary Hospital

jasfly77@vip.163.com+86 13818815584

Outcome results

None listed

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