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A prospective, multicenter study: assessment of efficacy and safety of SBRT combined withindividualized specific activated T cells immunotherapy (TAA-sT/IMPACT) in advanced stage none-small cell lung cancer

A prospective, multicenter, randomrized phase II trial: assessment of efficacy and safety of SBRT combined with individualized specific activated T cells immunotherapy (TAA-sT/IMPACT) in advanced stage none-small cell lung cancer after failure of second-line therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16008823
Enrollment
Unknown
Registered
2016-07-12
Start date
2016-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

lung cancer

Interventions

Therapy group 1:SBRT+TAA-sT immunotherapy
Therapy group 2:SBRT+IMPACT immunotherapy

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of none-small cell lung cancer; 2. Clinical stage IV accodring to AJCC Cancer Staging (Version 7); 3. Failure of second-line chemotherapy or targeted therapy; 4. Long diameter of >=2 measurement of disease >1.5 cm; 5. Aged more than 18 years; 6. ECOG performance status 3.5×10^9/L, hemoglobin > 90g/L and platelets > 100×10^9/L; 8. Normal renal function: Creatinine clearance > 60 ml/min; 9. Pulmonary function: (1) FEV1>30%; (2) DLCO>30%; 10. Signed written informed consent.

Exclusion criteria

Exclusion criteria: (1) Previous treatment including chemotherapy, radiotherapy, biological targeted therapy and immunotherapy within 4 weeks; (2) Expected survival time 3s or APTT > 10s; (4) A history of severe allergic reactions; (5) Pregnant and/or breastfeeding. Patients of childbearing potential must have a negative pregnancy test. Effective methods of contraception should be carried out during treatment; (6) Patients with other serious intercurrent illness including unstable angina which would interfere with drug, renal disease, chronic hepatitis, uncontrolled diabetes (fasting blood-glucose > 1.5×ULN), HIV/AIDS, uncontrolled infections and mental disorders; (7) Not suitable to be enrolled in the trial in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
Efficacy;

Secondary

MeasureTime frame
Overal survival;Progression-free survival;Time to progress;abscopal effect;Circulating tumor cell in peripheral blood;Quality of life;

Countries

China

Contacts

Public ContactYang Kunyu

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

yangky71@aliyun.com+86 13995595360

Outcome results

None listed

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