Clinical Study of a New Treatment Model for Elderly Lung Cancer Patients

A Multicenter Clinical Study on a New Treatment Model Combining New Surgical Techniques, Perioperative Comprehensive Treatment, and Postoperative Rehabilitation for Elderly Patients With Lung Cancer

This multicenter prospective clinical study focuses on elderly patients with lung cancer. We will build a standardized clinical registry database, develop perioperative risk stratification and surgical early-warning models, optimize individualized surgical regimens, construct multidisciplinary perioperative comprehensive therapy, integrated Chinese-Western medicine full-cycle management and personalized postoperative rehabilitation systems, so as to form a whole-process optimized treatment model for elderly lung cancer.

Study Overview

• Status: Recruiting
• Conditions: Perioperative Care; Aged; Lung Neoplasm; Thoracic Surgical Procedures; Postoperative Rehabilitation
• Intervention / Treatment: Procedure: Pulmonary Lobectomy plus Mediastinal Lymph Node Sampling; Procedure: Pulmonary Segmentectomy plus Mediastinal Lymph Node Sampling; Procedure: Pulmonary Wedge Resection plus Mediastinal Lymph Node Sampling

Detailed Description

This project consists of six interconnected research components around the whole-cycle management of elderly patients with lung cancer:

1. Construction of multicenter prospective cohort and clinical registry database for elderly lung cancer We will launch a prospective multicenter cohort study covering no less than 30 clinical centers and enrolling over 2000 elderly lung cancer patients to build a full-process clinical database. Core recorded indicators include comprehensive geriatric assessment, postoperative complications, overall survival, treatment-related adverse events and disease-free survival after recurrence.
2. Development and external validation of prognostic risk stratification and surgical safety early-warning system Based on existing geriatric disease data, we integrate multi-dimensional data including comprehensive geriatric status, comorbidities, imaging, pathology and molecular biomarkers to construct and iteratively optimize predictive models for surgical safety and long-term prognosis. The established risk stratification and early-warning system will be further validated using prospective multicenter cohort data.
3. Establishment and validation of optimized surgical strategy for elderly lung cancer By prospective multicenter clinical trial design, we compare long-term survival outcomes among radical resection, precision limited resection and palliative resection guided by preoperative risk stratification system, so as to formulate evidence-based optimized surgical selection framework for elderly early-stage lung cancer patients.
4. Development and validation of standardized perioperative comprehensive treatment strategy Relying on previous perioperative research data, multidisciplinary team is organized to establish adaptive perioperative comprehensive treatment guided by clinical characteristics, gene variation status and minimal residual tumor monitoring; meanwhile, a unified evaluation standard system for this comprehensive treatment mode will be constructed and verified.
5. Construction and validation of full-cycle collaborative management system combining traditional Chinese and western medicine We explore the evolution law of clinical symptom clusters and TCM deficiency syndrome across perioperative stages of elderly lung cancer, screen evidence-based traditional Chinese medicine intervention measures for different treatment phases, and establish and verify the full-cycle collaborative treatment system integrated western routine therapy and individualized Chinese herbal intervention.
6. Development and verification of individualized postoperative adaptive rehabilitation model With physical function, psychological status and nutritional level as core evaluation indicators, multidisciplinary rehabilitation team is set up to tailor personalized rehabilitation protocols for postoperative elderly patients. Combined with remote real-time monitoring and instant intervention intelligent platform, a novel adaptive postoperative rehabilitation model is built and prospectively validated in clinical practice.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Fan Yang, MD; Phone Number: 010-88326650; Email: 2311210336@pku.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged ≥65 years old
2. Pathologically confirmed non-small cell lung cancer with clinical stage eligible for curative surgical resection
3. Complete preoperative geriatric comprehensive assessment data available
4. Capable of finishing planned surgery and long-term follow-up
5. Voluntarily sign informed consent form

Exclusion Criteria:

1. History of other malignant tumors within recent 5 years
2. Severe organic dysfunction of heart, liver, renal or respiratory system that cannot tolerate thoracic surgery
3. Preoperative confirmed distant metastasis preventing radical resection
4. Uncontrolled active severe infection or obvious coagulation disorders
5. Severe psychiatric disorder or cognitive dysfunction failing to cooperate with treatment and follow-up
6. Refuse random grouping and postoperative regular monitoring

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lobectomy Group; Patients receive standard lobectomy plus mediastinal lymph node sampling for early-stage non-small cell lung cancer, for elderly patients ≥65 years with T1N0M0 tumor. Postoperative standard perioperative management and regular follow-up are conducted.	Procedure: Pulmonary Lobectomy plus Mediastinal Lymph Node Sampling; Standard anatomical lobectomy combined with systematic mediastinal lymph node sampling for early-stage T1N0M0 non-small cell lung cancer in patients aged ≥65 years; postoperative stratified adaptive perioperative management guided by MRD and tumor biomarkers.; Other Names: Standard Radical Lung Resection
Experimental: Segmentectomy Group; Patients receive anatomic segmentectomy plus mediastinal lymph node sampling. All enrolled elderly patients are stratified by tumor size and preoperative geriatric risk score before randomization, followed by unified postoperative monitoring and adaptive perioperative treatment based on MRD and biomarker results.	Procedure: Pulmonary Segmentectomy plus Mediastinal Lymph Node Sampling; Curative segmentectomy with mediastinal lymph node sampling after preoperative comprehensive geriatric risk assessment (CGA, VES-13, ASA grading); postoperative personalized perioperative treatment stratified by postoperative minimal residual disease status.; Other Names: Anatomic Sublobar Resection
Experimental: Wedge Resection Group; Patients receive pulmonary wedge resection plus mediastinal lymph node sampling. After surgery, low-risk patients get de-escalated adaptive perioperative treatment guided by postoperative MRD surveillance, while high-risk patients receive individualized intensive comprehensive therapy.	Procedure: Pulmonary Wedge Resection plus Mediastinal Lymph Node Sampling; Wedge resection plus mediastinal lymph node sampling for eligible elderly early lung cancer patients; low-risk subjects receive de-escalated adaptive perioperative treatment, while high-risk patients receive intensified comprehensive therapy based on postoperative risk stratification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	The time from randomization to all-cause death, to compare long-term survival difference among lobectomy, segmentectomy and wedge resection groups in elderly early-stage lung cancer patients.	Up to 5 years after surgical resection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Major Complications Rate	Incidence of grade ≥3 postoperative adverse complications within 90 days after surgery, comparing surgical safety across three resection strategies.	Within 90 days postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-Free Survival (DFS)	Time from randomization to tumor recurrence or death; explore recurrence difference guided by postoperative MRD-based adaptive perioperative treatment.	Up to 5 years after surgery

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Elderly lung cancer, Risk stratification, Multimodality therapy, Integrated Chinese and Western Medicine, Enhanced recovery after surgery
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2023ZD0501700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No