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临床试验/NCT06216782
NCT06216782招募中不适用

Exploring the Frontiers of Neoadjuvant Therapy for Lung Cancer: a Prospective Observational Real-world Study

Shanghai Pulmonary Hospital, Shanghai, China1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2023年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
Event-free survival (EFS)

研究概览

简要总结

Lung cancer is a malignant tumor with the highest incidence and mortality rate of cancer patients worldwide. Traditional treatments for lung cancer include surgery, radiotherapy and chemotherapy, etc. Although the growth and spread of the tumor can be controlled to a certain extent, the cure rate for patients with progressive stage is still low and the prognosis is poor.

Neoadjuvant therapy intends to use chemotherapy, immunotherapy, and targeted therapy to reduce the size and load of the tumor before surgery, to improve the surgical resection rate and therapeutic effect.

  1. Primary research objective: to explore the therapeutic efficacy of patients with different characteristics under different neoadjuvant therapeutic regimens.
  2. Secondary objectives To investigate the strengths and weaknesses of different neoadjuvant regimens in real-world clinical practice, and to investigate the long-term outcomes of patients treated with different regimens.

详细描述

Lung cancer is a malignant tumor with the highest incidence and mortality rate of cancer patients worldwide. Traditional treatments for lung cancer include surgery, radiotherapy and chemotherapy, etc. Although the growth and spread of the tumor can be controlled to a certain extent, the cure rate for patients with progressive stage is still low and the prognosis is poor.

Neoadjuvant therapy intends to use chemotherapy, immunotherapy, and targeted therapy to reduce the size and load of the tumor before surgery, to improve the surgical resection rate and therapeutic effect. In lung cancer treatment, neoadjuvant therapy has rate and quality of life. However, a meta-analysis confirmed that although neoadjuvant chemotherapy can significantly improve survival compared to surgery alone, with an OS HR of 0.8, the improvement in 5-year survival is only 5%. Neoadjuvant radiotherapy alone, even if it can lead to pathological remission in resected specimens, does not improve resectability or overall survival. The goal of preoperative radiotherapy is to improve OS by reducing local tumor recurrence, which is the primary goal in patients with Pancoast syndrome, for example, in whom localized lung loss has an impact on quality of life. In the literature, it has been reported that in the early treatment experience of patients with Pancoast syndrome, the percentage of incompletely resected tumors was reduced by neoadjuvant radiotherapy. The MPR or pCR rate of neoadjuvant NSCLC treatment with conventional chemotherapy and radiotherapy is less than 10%, and the improvement in 5-year overall survival is only 5%, suggesting that its efficacy is very limited.

  1. Primary objective The primary objective of the study is to explore the efficacy of neoadjuvant therapy in patients with different characteristics under different neoadjuvant therapy regimens.
  2. Secondary objectives To investigate the strengths and weaknesses of different neoadjuvant regimens in real-world clinical practice, and to investigate the long-term outcomes of patients treated with different regimens.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than or equal to 18 years;
  • Pathohistologically confirmed diagnosis of non-small cell lung cancer or small cell lung cancer;
  • Received neoadjuvant therapy after diagnosis;
  • Written informed consent.

排除标准

  • Patients enrolled in other clinical trials;
  • Patients refused enrollment in this study;
  • Patients refused follow-up.

结局指标

主要结局

Event-free survival (EFS)

时间窗: 5 years

The time from diagnosis until progression, recurrence, or death from any cause.

次要结局

  • Surgical conversion rate and objective response rate (ORR)(3 to 6 months)

研究者

发起方
Shanghai Pulmonary Hospital, Shanghai, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peng Zhang

Vice-President

Shanghai Pulmonary Hospital, Shanghai, China

研究点 (1)

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