Multicentric Database for KRAS Mutant Pancreatic Cancer

NCT07557849 | Not Yet Recruiting DMC

• 1 other identifier: PTCA199-17
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; KRAS; targeted therapy; real-world evidence; cohort

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

  12 months

Secondary Outcomes (1)

• Progression free survival (PFS)

  up to 10 years

Study Arms (1)

Pancreatic cancer with KRAS mutation

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is a multicenter real-world data collection research . It aims to establish a multicenter real-world evidence (RWE) database for KRAS-targeted therapy in pancreatic cancer. The study will retrospectively collect clinical data of pancreatic cancer patients with KRAS mutations previously diagnosed and treated at the Shanghai Pancreatic Cancer Institute , and prospectively collect clinical information from similar patients treated at the same institute. The database will be regularly updated and maintained. Clinical data of KRAS-mutant pancreatic cancer patients from domestic and international pancreatic tumor centers will be collected and periodically updated. Identifiable personal information such as ID numbers and names will be removed to enable multicenter collaboration and ensure patient privacy, with the goal of generating reliable evidence-based medical data .

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Related Publications (1)

• Park W, Kasi A, Spira AI, Paz-Ares Rodriguez L, Herzberg BO, Pelster MS, Tolcher AW, Kuboki Y, Kitano S, Shoji H, Wang JS, Berlin JD, Hollebecque A, LoRusso P, Fountzilas C, Cassier PA, Nishina T, Sakai D, Inagaki C, Morgensztern D, Ueno M, Jung M, Kim SW, Janne PA, Italiano A, You B, Macarulla T, Fujii H, Shetty A, Lu Y, Cui D, Kadam S, Gill SC, Toyoshima J, Saito T, Goldman JW. Setidegrasib in Advanced Non-Small-Cell Lung Cancer and Pancreatic Cancer. N Engl J Med. 2026 Apr 9;394(14):1409-1420. doi: 10.1056/NEJMoa2600752. Epub 2026 Mar 25.

  PMID: 41879829 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Guopei Luo

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Liu, MD

CONTACT

86 21-64175590; liuyi@fudanpci.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 30, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE