Pancreatic CancerNCT07557849
Multicentric Database for KRAS Mutant Pancreatic Cancer
An observational study of Pancreatic Cancer, run by Fudan University at 1 site in China.
Trial summary
Construction and Maintenance of a Precision Subtyping-Based Clinical Cohort for Targeted Therapy in KRAS-Mutant Pancreatic Cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2026to 30 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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 .
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Pancreatic Surgery
Shanghai, 200032
About this study
Official title: Construction and Maintenance of a Precision Subtyping-Based Clinical Cohort for Targeted Therapy in KRAS-Mutant Pancreatic Cancer
Construction and Maintenance of a Precision Subtyping-Based Clinical Cohort for Targeted Therapy in KRAS-Mutant Pancreatic Cancer
Read the 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:
- 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;
- Prospectively collecting clinical information from pancreatic cancer patients treated at the same institutions, with regular updates and maintenance of the pancreatic tumor RWE database.
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, KRAS, targeted therapy, real-world evidence, cohort
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic cancer with KRAS mutation | Patients with pancreatic cancer with KRAS mutation who received KRAS targeted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
OS: OS of subjects from recruiting to the time of death from any cause
Measured: 12 months
Secondary outcomes (1)
Progression free survival (PFS)
Progression free survival (PFS) is calculated from the date of starting KRAS targted therapy and ends when the first event (progression/death) occurs.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start22 May 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guopei Luo, Fudan University
- Investigators
- Guopei Luo, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557849
- Sponsor's protocol ID
- PTCA199-17
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 41879829
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Maintenance of a Precision Subtyping-Based Clinical Cohort for Targeted Therapy in KRAS-Mutant Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07557849
- Acronym / sponsor ID
- PTCA199-17
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, KRAS, targeted therapy, real-world evidence, cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 22 May 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- Prospectively collecting clinical information from pancreatic cancer patients treated at the same institutions, with regular updates and maintenance of the pancreatic tumor RWE database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic cancer with KRAS mutation | – | –Patients with pancreatic cancer with KRAS mutation who received KRAS targeted therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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 .
Key inclusion criteria (4 listed)
- No restrictions on age, gender, or performance status score;
- ④ Able to comply with the study visit schedule requirements;
- ⑤ Voluntarily participate and sign the informed consent form.
Key exclusion criteria (2 listed)
- Non-neoplastic pancreatic lesions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 12 months
OS: OS of subjects from recruiting to the time of death from any cause
1 secondary outcome
Progression free survival (PFS)
Time frame: up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 41879829Park 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guopei Luo principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Liu, MD (86 21-64175590, liuyi@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07557849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.