Pancreatic cancer, gastric cancer and cholangiocarcinoma
Conditions
Interventions
Control group (clinical conventional treatment group):None
Intervention group (the group using the digital twin model for prediction):None
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, both genders. 2. ECOG performance status 0-1. 3. Expected survival >=3 months. 4. Histologically or cytologically confirmed locally advanced unresectable or metastatic gastric cancer or pancreatic cancer. 5. At least one measurable lesion according to RECIST 1.1 criteria. 6. No prior systemic antitumor therapy before enrollment. 7. Major laboratory tests within normal limits. 8. Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days before starting study medication, and must agree to use a medically recognized highly effective contraceptive method (e.g., intrauterine device, contraceptive pill, or condom) during the study period and for 180 days after the last dose of study drug; male subjects with female partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study period and for 180 days after the last dose of study drug. 9. Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with uncontrolled or poorly controlled cardiac disease and any severe or uncontrollable systemic disease, active bleeding, history of coagulation disorders, or patients receiving coumarin anticoagulant therapy. 2. Patients with active pulmonary tuberculosis infection within 1 year before the first dose. 3. Patients with myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval >=450 ms for males and >=470 ms for females), NYHA class III-IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) <50% on echocardiography. 4. Patients with a history of severe hemorrhagic events or arterial/venous thrombosis, or pulmonary embolism. 5. Patients with known mental disorders or drug abuse, and female patients who are pregnant, breastfeeding, or planning to become pregnant during the study. 6. Any conditions that, in the investigator's opinion, may have contraindications to conventional treatment, harm the subject, or prevent the subject from meeting or performing the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival(PFS);Accuracy of Treatment Response Prediction;Treatment-Related Mortality Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR);Disease control rate(DCR);Overall survival period(OS);Duration of objective remission (DoR);Adverse event; | — |
Countries
China
Contacts
Public ContactZheng Li
West China Hospital of Sichuan University
Outcome results
None listed