Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery
Launched by GUANGDONG PROVINCIAL PEOPLE'S HOSPITAL · Dec 5, 2022
Trial Information
Current as of January 13, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new way to detect and monitor non-small cell lung cancer (NSCLC) in patients who have a limited number of metastases (spread of cancer) and are undergoing surgery. The researchers want to see if a test called liquid biopsy, which looks for cancer DNA in the blood, is a practical option for these patients. This trial is currently recruiting participants who are 18 years or older, generally healthy enough to undergo surgery, and have certain types of cancer spread that can be surgically removed.
To participate, patients need to provide written consent and must be able to follow the study requirements. Those with other serious health issues, past autoimmune diseases, or certain recent medical conditions may not qualify. If eligible, participants can expect to undergo some tests and surgeries and will be monitored closely throughout the study. This trial aims to improve how doctors can manage and treat patients with this specific type of lung cancer, potentially leading to better outcomes.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Written informed consent must be obtained from patients and ability for patients to comply with the requirements of the study;
- • Patients must be a man or woman of more than 18 years;
- • ECOG PS ≦1;
- • The function of the organs was evaluated by the surgeon to tolerate local surgical treatment;
- • The classification was evaluated as simultaneous oligometastases at initial treatment or oligoresidual/oligoprogression/oligorecurrence after induction therapy; \[Define: Initial treatment of simultaneous oligometastases: without systemic treatment, at the time of diagnosis, up to 5 metastases and up to 3 organs were involved, excluding pleural metastases or myeloid metastases.
- • Oligoresidual after induction therapy: after systemic therapy, distant metastases were stable or reduced, primary lesions were stable or reduced, PET/CT metabolism was reduced, and no more than 5 residual lesions and no more than 3 organs were involved.
- • Oligoprogression after induction therapy: After systemic therapy, some lesions were stable or reduced, while some original lesions were larger than before.
- • Oligorelapses after induction therapy: after systemic therapy, systemic lesions were stable or reduced, and new local lesions appeared.\]
- • Lesion evaluation can be surgically removed. \[Definition of operable resection: the lesion is limited and can be completely removed through surgery as assessed by the surgeon, with no significant impact on postoperative quality of life. Pulmonary surgical procedures include lobectomy, segmental resection and wedge resection. Pneumonectomy is not included.\]
- Exclusion Criteria:
- • Patients with a confirmed or suspected autoimmune disease;
- • Patients with a history of human immunodeficiency virus (HIV) positive or acquired immunodeficiency syndrome (AIDS);
- • Patients with a history of any arterial thrombosis within 6 months and history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months;
- • Patients with any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.);
- • Patients with a history of other malignancies in the past 5 years;
- • Patients identified by the investigators patients with contraindications to local treatment;
- • Patients with serious mental illness;
- • Patients who cannot sign informed consent;
- • Patients who cannot be followed up as scheduled;
Trial Officials
Wen-Zhao Zhong, Ph.D
Principal Investigator
Guangdong Provincial People's Hospital
About Guangdong Provincial People's Hospital
Guangdong Provincial People's Hospital is a leading tertiary healthcare institution located in Guangdong Province, China, renowned for its comprehensive medical services and advanced research capabilities. As a prominent clinical trial sponsor, the hospital is dedicated to advancing medical science through innovative research and the rigorous evaluation of new therapies and interventions. With a multidisciplinary team of experienced clinicians and researchers, the institution prioritizes patient safety and ethical standards while fostering collaborations with academic and industry partners to enhance healthcare outcomes and contribute to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Guangzhou, Guangdong, China
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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