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A prospective controlled clinical study of CalliShperes microsphere chemoembolization with concurrent intravenous chemotherapy for first-line treatment of patients with gene-negative non-small cell lung cancer oligometastase

A prospective controlled clinical study of CalliShperes microsphere chemoembolization with concurrent intravenous chemotherapy for first-line treatment of patients with gene-negative non-small cell lung cancer oligometastase

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024209
Enrollment
Unknown
Registered
2019-06-30
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-07-01

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:CalliSpheres microsphere chemoembolization with simultaneous intravenous chemotherapy
Control group:Systemic intravenous chemotherapy

Sponsors

Lishui Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 70 years; 2. Pathological diagnosis is clear, patients with stage IV lung cancer extracranial oligometastasis who are unable or unwilling to undergo surgery, less than 5 metastases; newly diagnosed and retreated patients with adjuvant chemotherapy or radiotherapy while the recurrence time was more than 1 year; 3. Tissue or plasma gene testing of common lung cancer driving genes such as EGFR, ALK, ROS, RET, HER2, MET and BRAF was negative. Or those without reachable targeted drugs or cannot tolerate targeted drugs; 4. Measurable lesions with observable evaluation (on CT images, lesions >=1 cm); 5. Absolute neutrophils >=2.0x10^9 /L, platelet >= 100x10^9 /L, hemoglobin >= 90g /L; coagulation function: prothrombin time < 15 seconds, partial thromboplastin time < 50S; renal function: creatinine, urea nitrogen normal; liver function: transaminase does not exceed 3 times of normal high limit; normal electrocardiogram; no active infection; 6. Expected survival time is more than 3 months; 7. Good physical condition, ECOG PS score 0 to 2 points; 8. Patient and family informed consent and signed informed consent consent.

Exclusion criteria

Exclusion criteria: 1. Pregnancy, lactating women or family planning patients of reproductive age; 2. Severe heart, liver and kidney dysfunction; 3. Who is expected to be unable to tolerate treatment; 4. Multiple nodules in the lung, single Pulmonary>3, double lung>5; 5. Definite brain metastasis; 6. Pulmonary insufficiency, presence of heavier emphysema or pulmonary bullae; unable to tolerate pulmonary puncture.

Design outcomes

Primary

MeasureTime frame
Radical thermal ablation rate of target lesions with oligometastase;Progression-free survival time;

Secondary

MeasureTime frame
New lesion appearance time;Overall survival;Quality of Life;

Countries

China

Contacts

Public ContactJiansong Ji

Lishui Central Hospital

jjstcty@sina.com+86 13857088508

Outcome results

None listed

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