A Study on Multimodal Prognostic Scoring of Advanced PDAC.

NCT07373691 | Enrolling By Invitation

• 1 other identifier: IIT-PDAC-MPS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 evaluate their predictive efficacy.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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

  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.

Study Arms (1)

Observation group

Eligibility Criteria

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

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.

You may qualify if:

• \. Patients with pancreatic ductal adenocarcinoma diagnosed by histology or cytology;
• \. Male or female patients aged ≥ 18 years old;
• \. In the past, except for first-line treatment, he has not received systematic treatment for unresectable local advanced or metastatic pancreatic cancer;
• \. Have complete blood routine, biochemical, and tumor marker blood tests before first-line maintenance treatment;
• According to RECIST 1.1 standard, there are measurable lesions at baseline;
• \. ECOG physical fitness score is 0-1;
• \. Expected lifespan of at least 3 months (assessed by researchers);
• \. Female patients must be in a non pregnant and non lactating state.
• \. Understand the significance of the purpose of this study and sign an informed consent form.

You may not qualify if:

• \. 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.).
• \. Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation.
• \. Receive live vaccines (including attenuated live vaccines) within 28 days before receiving first-line maintenance treatment.
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. Uncontrolled cancer pain, where the anesthetic analgesics did not reach a stable dose at the time of enrollment.
• \. 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.
• \. 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.
• \. There is clinical or imaging evidence of intestinal obstruction, or the etiology of recurrent intestinal obstruction has not been ruled out.
• \. There is active infection with poor systemic treatment control.
• \. 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.
• \. 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.
• \. It is known that there are mental illnesses or substance abuse conditions that can interfere with patients' compliance to participate in the study.

Sponsors & Collaborators

• RenJi Hospital: lead
• Shanghai Zhongshan Hospital: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator

Study Sites (1)

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Study Officials

• Qing Xia

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 28, 2026
• Study Start: March 2, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)