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临床试验/NCT07557849
NCT07557849招募中不适用

Construction and Maintenance of a Precision Subtyping-Based Clinical Cohort for Targeted Therapy in KRAS-Mutant Pancreatic Cancer

Fudan University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Overall survival

研究概览

简要总结

Construction and Maintenance of a Precision Subtyping-Based Clinical Cohort for Targeted Therapy in KRAS-Mutant Pancreatic Cancer

详细描述

Pancreatic cancer is one of the most aggressive tumors in the digestive system, often referred to as the "king of cancers". Globally, its incidence and mortality rank 12th and 7th among all malignant tumors. According to the American Cancer Society, pancreatic cancer is projected to become the second leading cause of cancer-related death in the US by 2030.

KRAS gene mutations are the most common genetic alterations in pancreatic cancer, occurring in approximately 90% of patients, with subtypes such as G12D, G12V, and G12R being particularly prevalent. Conventional chemotherapy and radiotherapy offer limited efficacy and are associated with significant side effects.

With advances in precision medicine, targeted therapy has emerged as a promising treatment strategy. Substantial progress has been made in developing KRAS-targeted drugs, some of which have entered clinical trials and shown encouraging results. However, due to the complexity and heterogeneity of KRAS mutations, patient responses to targeted therapy vary significantly. Therefore, it is essential to establish a prospective cohort study to comprehensively evaluate the efficacy and safety of KRAS-targeted therapies and inform clinical decision-making.

We aim to construct a clinical cohort for KRAS-mutant pancreatic cancer patients undergoing targeted therapy, with the goal of building a database system aligned with both clinical practice and research needs. This study consists of two components:

  1. Designing and implementing a database tailored to real-world clinical scenarios, retrospectively collecting clinical data from pancreatic tumor patients treated at the Shanghai Pancreatic Cancer Institute and multiple domestic and international centers, thereby establishing a real-world evidence (RWE) database;
  2. Prospectively collecting clinical information from pancreatic cancer patients treated at the same institutions, with regular updates and maintenance of the pancreatic tumor RWE database.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • No restrictions on age, gender, or performance status score;
  • Pathologically or cytologically confirmed pancreatic adenocarcinoma; ③ Known KRAS mutation subtype and has received treatment with KRAS-targeted agents;
  • ④ Able to comply with the study visit schedule requirements;
  • ⑤ Voluntarily participate and sign the informed consent form.

排除标准

  • Non-neoplastic pancreatic lesions;
  • Non-primary pancreatic neoplastic lesions; ③ Unable to comply with the study visit schedule requirements; ④ Refuse to participate and sign the informed consent form.

研究组 & 干预措施

Pancreatic cancer with KRAS mutation

Patients with pancreatic cancer with KRAS mutation who received KRAS targeted therapy

结局指标

主要结局

Overall survival

时间窗: 12 months

OS: OS of subjects from recruiting to the time of death from any cause

次要结局

  • Progression free survival (PFS)(up to 10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guopei Luo

Prof.

Fudan University

研究点 (1)

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