Borderline resectable or locally advanced pancreatic cancer
Conditions
Interventions
Experiment Group:Sintilimab in combination with nab-paclitaxel, gemcitabine, and thymalfasin
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Signed written informed consent must be obtained before initiation of any trial-related procedures. 2.Male or female participants aged >=18 years. 3.Histologically or cytologically confirmed pancreatic cancer assessed by the investigator, classified as borderline resectable pancreatic cancer or potentially resectable locally advanced pancreatic cancer. According to the 2024 CSCO Pancreatic Cancer Guidelines, the definition of borderline resectable pancreatic cancer includes: (1) Tumor abutment of the portal vein–superior mesenteric vein (PV–SMV) >180°, or =12 weeks. 7.At least one measurable lesion according to RECIST v1.1. 8.ECOG performance status (PS) score of 0–1. 9.Adequate organ function; 10.For women of childbearing potential: A negative urine or serum pregnancy test within 3 days prior to first dose on Cycle 1 Day 1. If urine pregnancy test results are equivocal, a serum test is required. Women must agree to use an appropriate contraceptive method during the observation period and for 8 weeks after the last dose of the investigational product. Non-childbearing potential is defined as >=1 year of amenorrhea, or surgical sterilization (e.g., bilateral oophorectomy or hysterectomy). 11.All participants (regardless of sex) with reproductive potential must agree to use effective contraceptive methods with an annual failure rate of <1% throughout the treatment period and for 120 days after the last dose of the investigational drug (or 180 days after the last dose of chemotherapy), whichever is later.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of any malignancy other than pancreatic cancer within 5 years prior to first dose (excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has been completely resected). 2.Currently participating in an interventional clinical study or having received investigational drugs or devices within 4 weeks prior to the first dose. 3.Prior treatment with PD-1, PD-L1, or PD-L2 inhibitors, or any agents targeting co-stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137). 4.Receipt of traditional Chinese medicine with anti-tumor indications or immunomodulatory agents (e.g., thymosin, interferon, interleukin—excluding local use for ascites control) within 2 weeks prior to the first dose. 5.Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to the first dose. Replacement therapies (e.g., thyroid hormone, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments. 6.Receiving systemic corticosteroids (excluding intranasal, inhaled, or topical corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first dose. Note: Physiologic doses of corticosteroids (=2), or recent (within 6 months) arterial thromboembolic events such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. 3) Poorly controlled hypertension (systolic BP >140 mmHg, diastolic BP >90 mmHg). 4) History of non-infectious pneumonitis requiring corticosteroid therapy within 1 year, or current active interstitial lung disease. 5) Active pulmonary tuberculosis. 6) Active or uncontrolled infections requiri
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate;Pathological complete response;Safety;Overall survival;Event-free survival; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactQin Lei; Xue Xiaofeng
The First Affiliated Hospital of Soochow University
Outcome results
None listed