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To evaluate the efficacy and safety of EqualSpheres microspheres loaded with vinorelbine in the treatment of patients with non-small cell lung cancer and obstructive lesions who have failed standard treatments.

To evaluate the efficacy and safety of EqualSpheres microspheres loaded with vinorelbine in the treatment of patients with non-small cell lung cancer and obstructive lesions who have failed standard treatments. - SPIRT1201

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080352
Enrollment
Unknown
Registered
2024-01-26
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-01-28

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:Drug-loaded microsphere embolization therapy

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Non-small cell lung cancer confirmed by histology or cytology, and chest CT within 1 week shows that the distal part of the main lesion is combined with obstructive inflammation or obstructive atelectasis (2) There is at least one measurable lesion (evaluated according to RECIST1.1 standards) with clinical TNM stage III and above. The staging should be based on the 8th edition of the International Union Against Cancer (UICC) staging criteria. (3) Non-small cell lung cancer patients who have failed standard second-line treatment based on the "Guidelines for Diagnosis and Treatment of Lung Cancer (2022 Edition)" (4) Age: 18-85 years old (5) There are no significant abnormalities in laboratory tests (blood routine, liver and kidney function, coagulation function, etc.): ?Routine blood examination standards must meet the following standards WBC=3.0×109/L; PLT=100×109/L; HGB=10.0g/L; NEUT#=1.5×109/L ?Biochemical examination must meet the following standards: liver function: ALT, AST= 1.5 ULN; b. BIL=1.5 ULN; Kidney function: Cr=1.5 ULN; b. BUN: 2.86-7.14mmol/L (6) ECOG = 3 points (7) Expected survival = 3 months (8) The subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with the follow-up

Exclusion criteria

Exclusion criteria: (1) Patients with other malignant tumors (2) Uncontrolled remote metastasis (3) Patients with a history of major diseases involving the heart, kidneys, liver, bone marrow, or central nervous system (4) Patients with uncontrolled diabetes, hypertension or ischemic heart disease (5) Pregnant or lactating women (6) The researcher determines that the clinical conditions are not suitable for D-BACE (arterial puncture contraindications) (7) Patients with obvious arteriovenous fistula (8) Preoperative CTA showed no obvious tumor supplying arteries to the systemic circulation. (9) Those who are allergic to vinorelbine or those who are severely allergic to iodine contrast media (10) Patients who, according to the researcher’s judgment, have concomitant diseases that seriously endanger patient safety or affect patients’ completion of the study (11) Patients who are currently participating in or participated in other clinical trials within 4 weeks before surgery (12) Patients with mental illness or history of psychotropic drug abuse

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
OS;PFS;Improvement rate of pulmonary obstructive lesions;AE;Quality of life score;

Countries

China

Contacts

Public ContactSen Jiang

Shanghai Pulmonary Hospital

jasfly77@vip.163.com+86 15 381 881 5584

Outcome results

None listed

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