Pancreatic cancer
Conditions
Interventions
Group A:Chidamide + Sintilimab + S-1
Group B:Irinotecan Liposome + S-1
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Written informed consent must be obtained prior to any trial-related procedures, and family members agree to cooperate with survival follow-up. 2.Male or female, aged >= 18 years; 3.Histologically or cytologically confirmed pancreatic ductal adenocarcinoma. 4.Second-line treatment; no prior fluoropyrimidine-based chemotherapy (including 5-FU, capecitabine, or S-1) in the first-line setting. Patients who received adjuvant chemotherapy with nab-paclitaxel plus gemcitabine or gemcitabine monotherapy and developed recurrence or metastasis within 6 months after completion are eligible. Patients previously treated with immune checkpoint inhibitors (except sintilimab) are allowed; 5.Life expectancy >= 3 months; 6.At least one measurable lesion as defined by RECIST 1.1 criteria; 7.ECOG Performance Status of 0 or 1; 8.Adequate organ function, meeting the following laboratory parameters within 14 days prior to treatment: Absolute neutrophil count (ANC) >= 1.5 × 10^9/L without granulocyte colony-stimulating factor support within 14 days. Platelet count >= 100 × 10^9/L without transfusion within 14 days. Hemoglobin >90 g/L without transfusion or erythropoietin use within 14 days. Total bilirubin ULN with direct bilirubin = 60 mL/min. Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 × ULN. Myocardial enzyme profile within normal limits (isolated laboratory abnormalities deemed clinically insignificant by the investigator are allowed). 9.Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose of study drug (Cycle 1 Day 1). If urine pregnancy test is positive or equivocal, a serum pregnancy test is required. They must agree to use highly effective contraception (with a failure rate of <1% per year) during the treatment period and for at least 8 weeks after the last dose of study drug. Non-childbearing potential is defined as being postmenopausal for at least 1 year, or surgically sterilized. Male subjects must use effective contraception during the treatment period and for at least 8 weeks after the last dose of study drug. 10.All subjects (male and female) with reproductive potential must use highly effective contraception throughout the treatment period and for 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy, if applicable).
Exclusion criteria
Exclusion criteria: 1.Diagnosis of any malignancy other than pancreatic cancer within 5 years prior to the first dose (excluding adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection); 2.Current participation in an interventional clinical study, or treatment with other investigational drugs or use of investigational devices within 4 weeks prior to the first dose. 3.Systemic treatment with Chinese herbal medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for localized use for controlling ascites) within 2 weeks prior to the first dose; 4.Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment. 5.Systemic corticosteroid therapy (excluding intranasal, inhaled, or other routes of local corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first dose. *Note: Allowable use of physiologic doses of corticosteroids (15 IU/mL). 12.Administration of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1). Note: Inactivated viral vaccines for seasonal influenza administered within 30 days prior to the first dose are allowed; however, live attenuated influenza vaccines administered intranasally are not permitted. 13.Women who are pregnant or breastfeeding. 14.Clinically symptomatic pleural effusion and/or ascites requiring clinical intervention. 15.Presence of any severe or uncontrolled systemic disease, such as: Resting ECG showing significant and symptomatic abnormalities in rhythm, conduction, or morphology that are difficult to control, e.g., complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation; Unstable angina, congestive heart failure, chronic heart failure meeting New York Heart Association (NYHA) class >= 2; Any arterial thrombosis, embolism, or ischemia within 6 months prior to enrollmen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6 months PFS rate;disease control rate;12 months PFS rate;QoL;safety;overall survival;6 months OS rate;12 months OS rate;Objective response rate; | — |
Countries
China
Contacts
Public ContactLi Wei
The First Affiliated Hospital of Soochow University
Outcome results
None listed