RecruitingNCT06534489

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


Sponsor

Ruijin Hospital

Enrollment

50 participants

Start Date

Aug 31, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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.

Interventions

PROCEDUREneoadjuvant 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.


Locations(1)

Ruijin hospital

Shanghai, China

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NCT06534489


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