Lung NeoplasmNCT07632664
Clinical Study of a New Treatment Model for Elderly Lung Cancer Patients
A study testing Pulmonary Lobectomy plus Mediastinal Lymph Node Sampling, Pulmonary Segmentectomy plus Mediastinal Lymph Node Sampling and Pulmonary Wedge Resection plus Mediastinal Lymph Node Sampling in people with Lung Neoplasm and Thoracic Surgical Procedures, run by Peking University People's Hospital at 1 site in China.
Trial summary
This multicenter prospective clinical study focuses on elderly patients with lung cancer. The investigators will build a standardized clinical registry database, develop perioperative risk stratification and surgical early-warning models, optimize individualized surgical regimens, construct multidisciplinary… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lung Neoplasm, Thoracic Surgical Procedures, Perioperative Care
- What is being tested?
- Pulmonary Lobectomy plus Mediastinal Lymph Node Sampling, Pulmonary Segmentectomy plus Mediastinal Lymph Node Sampling and Pulmonary Wedge Resection plus Mediastinal Lymph Node Sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged ≥65 years old
- Pathologically confirmed non-small cell lung cancer with clinical stage eligible for curative surgical resection
- Complete preoperative geriatric comprehensive assessment data available
- Capable of finishing planned surgery and long-term follow-up
- Voluntarily sign informed consent form
Who cannot join
- History of other malignant tumors within recent 5 years
- Severe organic dysfunction of heart, liver, renal or respiratory system that cannot tolerate thoracic surgery
- Preoperative confirmed distant metastasis preventing radical resection
- Uncontrolled active severe infection or obvious coagulation disorders
- Severe psychiatric disorder or cognitive dysfunction failing to cooperate with treatment and follow-up
- Refuse random grouping and postoperative regular monitoring
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Fan Yang, MD, 010-88326650, 2311210336@pku.edu.cn
About this study
Official title: 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. The investigators 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.
Read the detailed description
This project consists of six interconnected research components around the whole-cycle management of elderly patients with lung cancer:
- Construction of multicenter prospective cohort and clinical registry database for elderly lung cancer The investigators 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.
- Development and external validation of prognostic risk stratification and surgical safety early-warning system Based on existing geriatric disease data, the investigators 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.
- Establishment and validation of optimized surgical strategy for elderly lung cancer By prospective multicenter clinical trial design, the investigators 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.
- 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.
- Construction and validation of full-cycle collaborative management system combining traditional Chinese and western medicine The investigators 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.
- 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.
- Conditions
- Lung Neoplasm, Thoracic Surgical Procedures, Perioperative Care, Postoperative Rehabilitation, Aged
- Being tested
- Pulmonary Lobectomy plus Mediastinal Lymph Node Sampling, Pulmonary Segmentectomy plus Mediastinal Lymph Node Sampling, Pulmonary Wedge Resection plus Mediastinal Lymph Node Sampling
- Keywords
- Elderly lung cancer, Risk stratification, Multimodality therapy, Integrated Chinese and Western Medicine, Enhanced recovery after surgery
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Lobectomy plus Mediastinal Lymph Node SamplingProcedure or surgery
Also called Standard Radical Lung Resection
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.
Pulmonary Segmentectomy plus Mediastinal Lymph Node SamplingProcedure or surgery
Also called Anatomic Sublobar Resection
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.
Pulmonary Wedge Resection plus Mediastinal Lymph Node SamplingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Lobectomy Group | Experimental | 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. Receives: Procedure: Pulmonary Lobectomy plus Mediastinal Lymph Node Sampling |
| Segmentectomy Group | Experimental | 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. Receives: Procedure: Pulmonary Segmentectomy plus Mediastinal Lymph Node Sampling |
| Wedge Resection Group | Experimental | 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. Receives: Procedure: Pulmonary Wedge Resection plus Mediastinal Lymph Node Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 years after surgical resection
Secondary outcomes (1)
Postoperative Major Complications Rate
Incidence of grade ≥3 postoperative adverse complications within 90 days after surgery, comparing surgical safety across three resection strategies.
Measured: Within 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Aug 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective parallel-group randomized controlled trial for elderly patients with early-stage lung cancer. Patients are stratified by tumor diameter and preoperative geriatric risk grading, then randomly assigned to different surgical resection arms (lobectomy, segmentectomy or wedge resection with lymph node sampling). Another parallel adaptive treatment cohort stratifies patients by postoperative recurrence risk based on MRD, gene and clinical biomarkers to receive individualized adjuvant de-escalated or standard perioperative treatment.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Fan, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632664
- Sponsor's protocol ID
- 2023ZD0501700
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07632664
- Acronym / sponsor ID
- 2023ZD0501700
- Conditions
- Lung Neoplasm, Thoracic Surgical Procedures, Perioperative Care, Postoperative Rehabilitation, Aged
- Keywords
- Elderly lung cancer, Risk stratification, Multimodality therapy, Integrated Chinese and Western Medicine, Enhanced recovery after surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter prospective clinical study focuses on elderly patients with lung cancer. The investigators 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.
Detailed description
This project consists of six interconnected research components around the whole-cycle management of elderly patients with lung cancer:
- Construction of multicenter prospective cohort and clinical registry database for elderly lung cancer The investigators 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.
- Development and external validation of prognostic risk stratification and surgical safety early-warning system Based on existing geriatric disease data, the investigators 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.
- Establishment and validation of optimized surgical strategy for elderly lung cancer By prospective multicenter clinical trial design, the investigators 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.
- 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.
- Construction and validation of full-cycle collaborative management system combining traditional Chinese and western medicine The investigators 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a prospective parallel-group randomized controlled trial for elderly patients with early-stage lung cancer. Patients are stratified by tumor diameter and preoperative geriatric risk grading, then randomly assigned to different surgical resection arms (lobectomy, segmentectomy or wedge resection with lymph node sampling). Another parallel adaptive treatment cohort stratifies patients by postoperative recurrence risk based on MRD, gene and clinical biomarkers to receive individualized adjuvant de-escalated or standard perioperative treatment.
| Arm | Type | Receives |
|---|---|---|
| Lobectomy Group | Experimental | Procedure: Pulmonary Lobectomy plus Mediastinal Lymph Node SamplingPatients 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. |
| Segmentectomy Group | Experimental | Procedure: Pulmonary Segmentectomy plus Mediastinal Lymph Node SamplingPatients 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. |
| Wedge Resection Group | Experimental | Procedure: Pulmonary Wedge Resection plus Mediastinal Lymph Node SamplingPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Aged ≥65 years old
- Pathologically confirmed non-small cell lung cancer with clinical stage eligible for curative surgical resection
- Complete preoperative geriatric comprehensive assessment data available
- Capable of finishing planned surgery and long-term follow-up
- Voluntarily sign informed consent form
Key exclusion criteria (6 listed)
- History of other malignant tumors within recent 5 years
- Severe organic dysfunction of heart, liver, renal or respiratory system that cannot tolerate thoracic surgery
- Preoperative confirmed distant metastasis preventing radical resection
- Uncontrolled active severe infection or obvious coagulation disorders
- Severe psychiatric disorder or cognitive dysfunction failing to cooperate with treatment and follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary Lobectomy plus Mediastinal Lymph Node SamplingAlso: Standard Radical Lung ResectionStandard 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. | Procedure or surgery | Lobectomy Group |
| Pulmonary Segmentectomy plus Mediastinal Lymph Node SamplingAlso: Anatomic Sublobar ResectionCurative 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. | Procedure or surgery | Segmentectomy Group |
| Pulmonary Wedge Resection plus Mediastinal Lymph Node SamplingWedge 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. | Procedure or surgery | Wedge Resection Group |
Primary outcome
Overall Survival (OS)
Time frame: Up to 4 years after surgical resection
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.
1 secondary outcome
Postoperative Major Complications Rate
Time frame: Within 90 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Lobectomy plus Mediastinal Lymph Node Sampling, Pulmonary Segmentectomy plus Mediastinal Lymph Node Sampling and Pulmonary Wedge Resection plus Mediastinal Lymph Node Sampling in people with Lung Neoplasm and Thoracic Surgical Procedures, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 4 years after surgical resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.