Pancreatic Cancer
Conditions
Keywords
pancreatic cancer, KRAS, targeted therapy, real-world evidence, cohort
Brief summary
Construction and Maintenance of a Precision Subtyping-Based Clinical Cohort for Targeted Therapy in KRAS-Mutant Pancreatic Cancer
Detailed description
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.
Interventions
None listed
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 12 months | OS: OS of subjects from recruiting to the time of death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | up to 10 years | Progression free survival (PFS) is calculated from the date of starting KRAS targted therapy and ends when the first event (progression/death) occurs. |
Countries
China
Contacts
CONTACTYi Liu, MD
PRINCIPAL_INVESTIGATORGuopei Luo
Fudan University
Outcome results
None listed