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Clinical Trials in China / NCT06534489
Recruiting Observational

Surgical Strategy of NSCLC Patients After Neo-adjuvant or Induction Treatment

NCT06534489 · tracked via the Priya Life Science China tracker
Sponsor
Ruijin Hospital
Phase
Observational
Started
2023-08-31
Last updated
2024-08-02

Condition(s) studied

Non-small Cell Lung CancerSurgery

Investigational drug(s) / intervention(s)

neoadjuvant immuno-chemotherapy and surgery

neoadjuvant immuno-chemotherapy and surgery: After enrolled, patients should receive neo-adjuvant immuno-chemotherapy and a re-evaluation will be performed after treatment to decide surgery strategy.

Study summary

Lung cancer is one of the most common malignant tumors worldwide and has the highest mortality rate among malignant tumors. In recent years, with the gradual development of therapeutic modalities such as targeted therapy and immunotherapy, the overall survival of lung cancer patients has improved significantly. However, late tumor staging at the time of diagnosis often leaves patients with only pneumonectomy, which affects the prognosis with a higher rate of postoperative complications than lobectomy, poorer quality of life and the possible loss of the opportunity to continue adjuvant therapy. Our group proposes to conduct this single-arm prospective clinical study to investigate the feasibility, safety and prognosis of the conversion from pneumonectomy to lobectomy after neoadjuvant or induction therapy in patients with operable non-small cell lung cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * The patients voluntarily participate in the study, have good compliance, can cooperate with the requirements of the experiment to complete the observation and follow-up, and sign the informed consent form. * Aged over 18 years old, under 75 years old; male and female are not limited; * Pathologically confirmed non-small cell lung cancer with clinical stage T2-4N0-2, resectable non-small cell lung cancer, potentially needing pneumonectomy and receiving neoadjuvant or induction therapy. * ASA score: Grade I-III; * The cardiopulmonary function evaluation can meet the requirements for radical lung cancer surgery, and the liver and kidney functions are normal. Exclusion Criteria: * Those with serious cardiac, pulmonary, hepatic, and renal dysfunctions, unable to tolerate the surgery; * Those with uncontrollable neurological or psychiatric diseases or mental disorders, poor compliance, and being unable to cooperate and describe the treatment response. * Those who are going to undergo emergency surgery or palliative surgery due to lung abscess or hemoptysis. * Those who have been treated, or are undergoing neoadjuvant or induction radiotherapy or targeted therapy. * Those who have a combined history of other malignant tumors * Those who have a history of thoracic surgery * Those who are pregnant or breastfeeding women * Patients of childbearing age who refuse to use contraception.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ruijin hospital Shanghai China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06534489 on ClinicalTrials.gov ↗ ← All trials in China