Liquid Biopsy-Based Novel Modality for Postoperative Management of Lung Cancer

NCT06930807 | Recruiting

• 1 other identifier: 2023ZD0501900
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to develop new techniques for minimal residual disease(MRD) monitoring and to confirm the efficacy and safety of MRD-guided postoperative management for early stage non-small cell lung cancer. The main questions this study aims to answer are:

• How to develop multi-omics-based high-sensitivity detection methods to accurately capture MRD and monitor postoperative recurrence in lung cancer?
• Is adaptive treatment guided by ctDNA-MRD for lung cancer patients superior to traditional clinical management and effectively improves survival?
• Do heterogeneous patient populations (grouped by stages, histopathological subtypes, driver mutations, and treatment histories) show differences in effects under ctDNA-MRD guided postoperative management strategies?

Conditions

Non-small Cell Lung Cancer; Minimal Residual Disease; Adaptive Treatment

Outcome Measures

Primary Outcomes (1)

• Two-year recurrence-free survival rate

  The difference in the proportion of patients with (suspected) relapse or metastasis between the intervention group and the control group within two years.

  Time from curative surgery to confirmation of clinical progression (recurrence or metastasis) within two years.

Secondary Outcomes (4)

• Overall survival

  Time from curative surgery to confirmation of death (any cause)，assessed up to 60 months.

• Incremental cost effectiveness ratio

  24 months after surgery

• Timely diagnosis rate by the novel MRD monitoring technique

  two years

• Sensitivity of the novel MRD monitoring approach

  two years

Study Arms (2)

adaptive postoperative management group

EXPERIMENTAL

For those who don't receive neoadjuvant therapy, if the MRD testing results after surgery keep negative, postoperative adjuvant therapy will be waived. For those who receive neoadjuvant therapy, if the efficacy reaches pathological complete response(pCR) and MRD testing results keep negative, postoperative adjuvant therapy will be waived. Otherwise, participants will receive a customized treatment plan based on Multi-disciplinary Treatment (MDT).

Other: Adaptive postoperative management based on minimal residual disease

standard clinical postoperative management group

NO INTERVENTION

These participants will receive standard postoperative adjuvant therapy and routine follow-up.

Interventions

Adaptive postoperative management based on minimal residual disease OTHER

participants will not receive postoperative treatment if (neoadjuvant therapy efficacy reaches pCR and) MRD results keep negative.

adaptive postoperative management group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-small cell lung cancer with stage IA-IIIA (8th edition TNM classification) planning to undergo curative surgery or to undergo neoadjuvant therapy
• Solid nodules \>1 cm or ground-glass nodules \>1.5 cm on imaging
• No history of malignancies other than non-small cell lung cancer in the past 5 years
• Specimens are well preserved and imaging documents are accessible.

You may not qualify if:

• Age\<18 years old
• Non-small cell lung cancer with pathologic stage IIIB-IV (8th edition TNM classification)
• Pathology results confirmed not to be non-small cell lung cancer
• History of malignancies other than non-small cell lung cancer in the past 5 years

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Peking University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Jiangsu Cancer Institute & Hospital: collaborator
• Shanghai Chest Hospital: collaborator
• Shandong Cancer Hospital and Institute: collaborator
• Shenzhen Third People's Hospital: collaborator
• Second Xiangya Hospital of Central South University: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Peking University First Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• National Institute for Occupational Safety and Health (NIOSH/CDC): collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kezhong Chen, MD

  Peking University People's Hospital

  STUDY CHAIR

• Guangxi Wang, PhD

  Peking University

  STUDY DIRECTOR

• Jiatao Zhang, MD

  Guangdong Provincial People's Hospital

  STUDY DIRECTOR

• Rong Yin, MD

  Jiangsu Cancer Institute & Hospital

  STUDY DIRECTOR

• Ziming Li, MD

  Shanghai Chest Hospital

  STUDY DIRECTOR

• Yintao Li, MD

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

• Zizi Zhou, MD

  Shenzhen Third People's Hospital

  PRINCIPAL INVESTIGATOR

• Fang Wu, MD

  Second Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• Jun Yin, MD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

• Yuan Cheng, MD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

• Quanfu Huang, MD

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

  PRINCIPAL INVESTIGATOR

• Xiaojun Zhu, PhD

  China National Institute for Occupational Safety and Health (NIOSH/CDC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kezhong Chen, MD

CONTACT

+86-010-88325983; mdkzchen@163.com

Xiaoqiu Yuan

CONTACT

+86-010-88325983; YuanXQ_pkuphxw@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 16, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

CN (1)