Clinical Study of a New Treatment Model for Elderly Lung Cancer Patients
2026年7月14日 更新者：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.
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.
調査の概要
状態
募集
詳細な説明
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.
研究の種類
介入
入学 (推定)
1000
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
Beijing Municipality
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Beijing、Beijing Municipality、中国、100044
- 募集
- Peking University People's Hospital
-
コンタクト：
- Fan Yang, MD
- 電話番号：010-88326650
- メール：2311210336@pku.edu.cn
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
他の名前：
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実験的：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.
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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.
他の名前：
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実験的：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Overall Survival (OS)
時間枠：Up to 4 years after surgical resection
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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.
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Up to 4 years after surgical resection
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postoperative Major Complications Rate
時間枠：Within 90 days postoperatively
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Incidence of grade ≥3 postoperative adverse complications within 90 days after surgery, comparing surgical safety across three resection strategies.
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Within 90 days postoperatively
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Disease-Free Survival (DFS)
時間枠：Up to 4 years after surgery
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Time from randomization to tumor recurrence or death; explore recurrence difference guided by postoperative MRD-based adaptive perioperative treatment.
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Up to 4 years after surgery
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年8月1日
一次修了 (推定)
2026年12月30日
研究の完了 (推定)
2028年8月31日
試験登録日
最初に提出
2026年6月2日
QC基準を満たした最初の提出物
2026年6月2日
最初の投稿 (実際)
2026年6月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月15日
QC基準を満たした最後の更新が送信されました
2026年7月14日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2023ZD0501700
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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