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

2 giugno 2026 aggiornato da: Yang Fan, MD, Peking University People's Hospital

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

1000

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100044
        • Reclutamento
        • Peking University People's Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: 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.
Altri nomi:
  • Standard Radical Lung Resection
Sperimentale: 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.
Procedura: 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.
Altri nomi:
  • Anatomic Sublobar Resection
Sperimentale: 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.
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: Up to 5 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.
Up to 5 years after surgical resection

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postoperative Major Complications Rate
Lasso di tempo: Within 90 days postoperatively
Incidence of grade ≥3 postoperative adverse complications within 90 days after surgery, comparing surgical safety across three resection strategies.
Within 90 days postoperatively

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Disease-Free Survival (DFS)
Lasso di tempo: Up to 5 years after surgery
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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Peking University People's Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 agosto 2024

Completamento primario (Stimato)

30 giugno 2026

Completamento dello studio (Stimato)

31 agosto 2028

Date di iscrizione allo studio

Primo inviato

2 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 giugno 2026

Primo Inserito (Effettivo)

8 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2023ZD0501700

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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