Pancreatic Ductal Adenocarcinoma (PDAC)NCT07373691
A Study on Multimodal Prognostic Scoring of Advanced PDAC.
An observational study of Pancreatic Ductal Adenocarcinoma (PDAC), run by RenJi Hospital at 1 site in China.
Trial summary
The aim of this study is to construct unimodal and multimodal prediction models for overall survival (OS), progression free survival (PFS), and treatment response (complete response+partial response) of advanced first-line chemotherapy based on the imaging, pathological, and genomic characteristics of patients, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC)
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2025to 1 Mar 2027
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. The retrospective training set consists of 300 cases from Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine; 2. The retrospective test set includes 50-100 cases from Zhongshan Hospital Affiliated to Fudan University, 50-100 cases from Third Hospital Affiliated to Zhongshan University, 50-100 cases from Sir Run Run Shaw Hospital Affiliated to Zhejiang University, 50-100 cases from Nanjing Drum Tower Hospital, and 178 cases from CPTAC-PDA database; 3. The prospective test set consists of 100 cases from Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.
Who may be able to join
- 1. Patients with pancreatic ductal adenocarcinoma diagnosed by histology or cytology;
- 2. Male or female patients aged ≥ 18 years old;
- 3. In the past, except for first-line treatment, he has not received systematic treatment for unresectable local advanced or metastatic pancreatic cancer;
- 4. Have complete blood routine, biochemical, and tumor marker blood tests before first-line maintenance treatment;
- 5.According to RECIST 1.1 standard, there are measurable lesions at baseline;
- 6. ECOG physical fitness score is 0-1;
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- 7. Expected lifespan of at least 3 months (assessed by researchers);
- 8. Female patients must be in a non pregnant and non lactating state.
- 9. Understand the significance of the purpose of this study and sign an informed consent form.
Who cannot join
- 1. Within 28 days prior to receiving first-line maintenance treatment, have undergone major surgery or trauma (such as major surgeries via abdomen, chest, etc.; excluding ultrasound-guided pancreatic fine needle aspiration biopsy [EUS-FNB], percutaneous liver biopsy, laparoscopic biopsy or subcutaneous mass resection biopsy, peripheral venous catheterization and biliary stent implantation, etc.).
- 2. Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation.
- 3. Receive live vaccines (including attenuated live vaccines) within 28 days before receiving first-line maintenance treatment.
- 4. Those who have previously or currently suffered from interstitial pneumonia/lung disease and have been determined by the researcher to be inactive and do not require hormone therapy are excluded.
- 5. Past or current autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome (granulomatous disease of polyangitis), Graves' disease, rheumatoid arthritis, pituitary inflammation, uveitis, autoimmune hepatitis, systemic sclerosis (scleroderma, etc.), Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain Barre syndrome), etc. Except for the following cases: type I diabetes, hypothyroidism with stable hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo without systemic treatment.
- 6. Within 14 days before receiving first-line maintenance therapy, systemic corticosteroids (>10mg/day prednisone or equivalent other corticosteroids, continuous treatment for ≥ 7 days) or immunosuppressive therapy are required. Excluding inhalation or local application of hormones; Or receiving physiological replacement doses of hormone therapy due to adrenal insufficiency; Allow short-term (<7 days) corticosteroids to be used for prevention (such as contrast agent allergies) or treatment of non autoimmune disorders.
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- 7. Other malignant tumors were combined within 5 years before receiving first-line maintenance treatment, except cured skin squamous cell carcinoma, basal cell carcinoma, non basic invasive bladder cancer, and prostate/cervical/breast cancer in situ.
- 8. It is known that there is active central nervous system (CNS) metastasis and/or malignant meningitis. Note: If a patient has previously received treatment for brain metastases and the lesion has been clinically or radiologically stable for at least 14 days prior to receiving first-line maintenance treatment (confirmed by repeated imaging studies at least 4 weeks apart and conducted during the screening period), they may be considered for inclusion.
- 9. Uncontrolled cancer pain, where the anesthetic analgesics did not reach a stable dose at the time of enrollment.
- 10. Compression fractures of the spine that have not been treated with surgery and/or radiation therapy; The treated spinal compression fracture requires at least 2 weeks of disease stabilization before receiving first-line maintenance treatment.
- 11. Presence of malabsorption syndrome, inability to take oral medication, or severe gastrointestinal diseases such as poorly controlled gastrointestinal inflammatory lesions (active Crohn's disease or ulcerative colitis), or high-risk gastrointestinal bleeding or abdominal bleeding.
- 12. There is clinical or imaging evidence of intestinal obstruction, or the etiology of recurrent intestinal obstruction has not been ruled out.
- 13. There is active infection with poor systemic treatment control.
- 14. Patients with known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or active syphilis and tuberculosis. Note: Subjects who are HbsAg positive and/or HCV antibody positive during the screening period must undergo HBV DNA or HCV RNA testing. If the test result is negative, they can be enrolled. HbsAg positive subjects must be monitored for HBV DNA during the treatment process.
- 15. Patients who are known to be allergic to drugs such as gemcitabine, albumin paclitaxel, capecitabine, 5-FU, or irinotecan, as well as their drug components, may be included in this study if they choose to receive maintenance treatment with oral or intravenous chemotherapy preparations other than the aforementioned allergic chemotherapy drugs.
- 16. It is known that there are mental illnesses or substance abuse conditions that can interfere with patients' compliance to participate in the study.
- 17. According to the researcher's determination, there are any medical history, treatment, laboratory test abnormalities, or other situations that may confuse the research results, interfere with patient compliance, or harm patient interests.
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
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
Official title: A Multimodal Prognostic Model for Advanced Pancreatic Ductal Adenocarcinoma Patients: a Retrospective and Prospective, Observational, Multicenter Study.
The aim of this study is to construct unimodal and multimodal prediction models for overall survival (OS), progression free survival (PFS), and treatment response (complete response+partial response) of advanced first-line chemotherapy based on the imaging, pathological, and genomic characteristics of patients, and evaluate their predictive efficacy.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
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 |
|---|---|---|
| Observation group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
The method of obtaining overall survival (OS) of patients mainly comes from two channels, forming data cross validation: one is the hospital electronic medical record system extracting patients' death records and follow-up records; The second is for researchers to conduct telephone follow-up to obtain the survival status outside the hospital.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary outcomes (2)
Progression free survival (PFS)
Method for obtaining progression free survival (PFS) of patients: treatment progression time, imaging examination reports, tumor markers, and clinical symptom records in hospital electronic medical records; And the patient follow-up examination data and symptom descriptions collected during the follow-up process.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
Treatment response
The method for obtaining the evaluation results of patient treatment response: The core data comes from imaging examination reports and tumor marker detection reports in hospital electronic medical records; The auxiliary data includes patient follow-up information collected during clinical symptom records and follow-up processes.
Measured: According to RECIST 1.1 criteria, what needs to be obtained in this section is the evaluation results of whether the patient has achieved complete response (CR) or partial response (PR) during the treatment cycle, up to 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start2 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Sir Run Run Shaw Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Third Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Principal investigator, Qing Xia, RenJi Hospital
- Investigators
- Qing Xia, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373691
- Sponsor's protocol ID
- IIT-PDAC-MPS
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD contains sensitive data of patients, and even after past identification processing, there is still a potential risk of privacy leakage. In addition, some informed consent forms did not explicitly include the clause of "IPD external sharing" when signed. If they are shared without the patient's supplementary authorization in the future, it will directly violate ethical approval requirements. 2\. There is a lack of clear standards for the ownership and division of responsibilities of the results after data use; Due to improper use of data leading to adverse consequences, it is difficult to clearly define the rights and responsibilities of researchers and data users, and researchers may face unnecessary legal disputes. In summary, the cautious attitude of researchers towards IPD sharing is essentially the result of seeking a balance between scientific value, ethical responsibility, practical costs, and rights protection.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Prognostic Model for Advanced Pancreatic Ductal Adenocarcinoma Patients: a Retrospective and Prospective, Observational, Multicenter Study.
- ClinicalTrials.gov ID
- NCT07373691
- Acronym / sponsor ID
- IIT-PDAC-MPS
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Sir Run Run Shaw Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Third Affiliated Hospital, Sun Yat-Sen University
- Study start
- 2 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 28 Jan 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.
The aim of this study is to construct unimodal and multimodal prediction models for overall survival (OS), progression free survival (PFS), and treatment response (complete response+partial response) of advanced first-line chemotherapy based on the imaging, pathological, and genomic characteristics of patients, and evaluate their predictive efficacy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. The retrospective training set consists of 300 cases from Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine; 2. The retrospective test set includes 50-100 cases from Zhongshan Hospital Affiliated to Fudan University, 50-100 cases from Third Hospital Affiliated to Zhongshan University, 50-100 cases from Sir Run Run Shaw Hospital Affiliated to Zhejiang University, 50-100 cases from Nanjing Drum Tower Hospital, and 178 cases from CPTAC-PDA database; 3. The prospective test set consists of 100 cases from Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.
Key inclusion criteria (9 listed)
- 1. Patients with pancreatic ductal adenocarcinoma diagnosed by histology or cytology;
- 2. Male or female patients aged ≥ 18 years old;
- 3. In the past, except for first-line treatment, he has not received systematic treatment for unresectable local advanced or metastatic pancreatic cancer;
- 4. Have complete blood routine, biochemical, and tumor marker blood tests before first-line maintenance treatment;
- 5.According to RECIST 1.1 standard, there are measurable lesions at baseline;
Key exclusion criteria (17 listed)
- 1. Within 28 days prior to receiving first-line maintenance treatment, have undergone major surgery or trauma (such as major surgeries via abdomen, chest, etc.; excluding ultrasound-guided pancreatic fine needle aspiration biopsy [EUS-FNB], percutaneous liver biopsy, laparoscopic biopsy or subcutaneous mass resection biopsy, peripheral venous catheterization and biliary stent implantation, etc.).
- 2. Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation.
- 3. Receive live vaccines (including attenuated live vaccines) within 28 days before receiving first-line maintenance treatment.
- 4. Those who have previously or currently suffered from interstitial pneumonia/lung disease and have been determined by the researcher to be inactive and do not require hormone therapy are excluded.
- 5. Past or current autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome (granulomatous disease of polyangitis), Graves' disease, rheumatoid arthritis, pituitary inflammation, uveitis, autoimmune hepatitis, systemic sclerosis (scleroderma, etc.), Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain Barre syndrome), etc. Except for the following cases: type I diabetes, hypothyroidism with stable hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo without systemic treatment.
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 (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
The method of obtaining overall survival (OS) of patients mainly comes from two channels, forming data cross validation: one is the hospital electronic medical record system extracting patients' death records and follow-up records; The second is for researchers to conduct telephone follow-up to obtain the survival status outside the hospital.
2 secondary outcomes
Progression free survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
Treatment response
Time frame: According to RECIST 1.1 criteria, what needs to be obtained in this section is the evaluation results of whether the patient has achieved complete response (CR) or partial response (PR) during the treatment cycle, up to 18 months.
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 28 Jan 2026.
- Individual participant dataSharing planned: No. IPD contains sensitive data of patients, and even after past identification processing, there is still a potential risk of privacy leakage. In addition, some informed consent forms did not explicitly include the clause of "IPD external sharing" when signed. If they are shared without the patient's supplementary authorization in the future, it will directly violate ethical approval requirements. 2. There is a lack of clear standards for the ownership and division of responsibilities of the results after data use; Due to improper use of data leading to adverse consequences, it is difficult to clearly define the rights and responsibilities of researchers and data users, and researchers may face unnecessary legal disputes. In summary, the cautious attitude of researchers towards IPD sharing is essentially the result of seeking a balance between scientific value, ethical responsibility, practical costs, and rights protection.
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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.
Qing Xia principal investigator
RenJi Hospital
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 Ductal Adenocarcinoma (PDAC), run by RenJi Hospital 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 9 inclusion and 17 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: enrolling by invitation, as of the sponsor's last update on 28 Jan 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2026.