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A prospective, single-arm, phase II clinical study of local ablative therapy for patients with advanced non-small cell lung cancer who had received immunotherapy and experienced oligo-progressive disease

A prospective, single-arm, phase II clinical study of local ablative therapy for patients with advanced non-small cell lung cancer who had received immunotherapy and experienced oligo-progressive disease

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036895
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

lung cancer

Interventions

local ablative therapy:local ablative therapy

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with unresectable advanced non-small cell lung cancer (stage IIIB and IV) confirmed by cytology or pathology; 2. Patients who received first-line immunotherapy (PD-1 / PD-L1 inhibitor) and had achieved partial response/complete response or stable disease >=6 months but experienced oligo-progressive disease ( 50% or normal range; neutrophil count > 1500 / mm3; Platelet count > 75000 / mm3; Creatinine clearance rate > 45ml / min; Total bilirubin < 1.5 times the upper limit of normal value (total bilirubin < 4 times the upper limit of normal value in patients with Gilbert's syndrome); Ast or ALT < 3 times of the upper limit of normal value (less than 5 times of the upper limit of normal value in patients with liver metastasis); 6. Patients over 18 years old; 7. Informed consent is in line with ICH-GCP principles.

Exclusion criteria

Exclusion criteria: 1. Patients with symptomatic brain metastasis; 2. Patients with previous or existing cardiovascular abnormalities, such as refractory hypertension, congestive heart failure (NYHA III), unstable angina or refractory arrhythmia, who had myocardial infarction in the first six months at random; 3. Patients with other serious persistent diseases or organ system dysfunction that the researchers believe may impair patient safety or interfere with the safety assessment of the investigational drug; 4. A woman of childbearing age of planned pregnancy or a man of childbearing age of planned parenthood; 5. Pregnant or lactating women; 6. Patients who could not follow the protocol provided by the investigator; 7. Patients with other contraindications for ablation.

Design outcomes

Primary

MeasureTime frame
Progression free survival;—

Secondary

MeasureTime frame
Overall survival;Time to local progression;—

Countries

China

Contacts

Public ContactZhou Fei

Shanghai Pulmonary Hospital

fei.zhou@tongji.edu.cn+86 13801751704

Outcome results

None listed

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