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Clinical study on the safety and efficacy of recombinant Human Tumor Necrosis Factor (TNF) in patients with stage IIB and III non-small cell lung cancer

Clinical study on the safety and efficacy of recombinant Human Tumor Necrosis Factor (TNF) in patients with stage IIB and III non-small cell lung cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060849
Enrollment
Unknown
Registered
2022-06-12
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

lung cancer

Interventions

Treatment group 2: When the chemotherapy medicines cause leukopenia or thrombocytopenia, Hematopoietic Stimulating Factors (HSF) can be given as a supportive treatment

Sponsors

The First Affiliated Hospital of Medical College of Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients with non-small cell lung cancer were diagnosed by imaging and histopathology, and the tumor stage was stage IIB or III; 2.Patients can undergo surgery; 3.Patients voluntarily participate and sign informed consent in writing; 4.Age 18-70 years old; 5.Card score >= 70, survival expectation >= 6 months; 6.Hemoglobin (Hgb) >= 80g / L, white blood cell (WBC) >= 3.5 × 10^9 / L (unit normal index), platelet (PLT) >= 100 × 10^9 / L (unit normal index), absolute neutrophil count (ANC) >= 1.5 × 10^9/L 7.Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 30g / L, serum total bilirubin <= 1.5 × ULN 8.Serum creatinine: renal function < 1.5 × ULN 9.ECG is normal; 10.no serious complications, such as hypertension, diabetes, coronary heart disease and mental illness.

Exclusion criteria

Exclusion criteria: 1.Patients with severe adverse reactions such as bone marrow suppression; 2.Subjects who have received other drug trials in recent 1 month; 3.Have a serious history of allergy or special constitution; 4.A history of severe lung or heart disease; 5.Refuse or fail to sign the informed consent to participate in the test; 6.Drug or alcohol addicts; 7.Having personality or mental illness, no civil capacity or limited civil capacity

Design outcomes

Primary

MeasureTime frame
Postoperative bleeding volume;Drainage volume;Length of stay;Postoperative complications;Recurrence rate;

Countries

China

Contacts

Public ContactJIan Hu
2854943026@qq.com+86 17816858920

Outcome results

None listed

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