Adebrelimab and Chidamide plus Gemcitabine as first-line treatment for advanced and metastatic pancreatic cancer patients (P-reCise/SCOG-P001): An exploratory, phase 2 trial.

Phase 2

Recruiting

Conditions: pancreatic cancer

Registration Number: ChiCTR2400079609

Lead Sponsor: First affiliated hospital of Soochow university

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

a. pathologically confirmed pancreatic cancer; b. Age =18 years old, gender unlimited; c. PS=1-2 d. Expected survival =3 months; e. Have at least one measurable lesion according to RECIST1.1 criteria; f. have not previously received any systemic antitumor therapy for advanced/metastatic disease. Patients who had previously received adjuvant/neoadjuvant chemotherapy, or radical chemoradiotherapy for advanced disease, if the interval between disease progression or recurrence and the end of the last drug treatment was at least 6 months, were admitted to the study. g. The major organs function well, that is, the relevant examination indicators within 14 days before enrollment meet the following requirements: Hemoglobin = 90 g/L (no transfusion within 14 days); Neutrophil count > 1.5×109/L; Platelet count = 100×109/L; Total bilirubin = 1.5×ULN (upper limit of normal); (In the presence of liver metastasis, =3×ULN) Serum glutamic pyruvic aminotransferase (ALT) or serum glutamic oxalacetic aminotransferase (AST) = 2.5×ULN; If there is liver metastasis, ALT or AST = 5×ULN; Endogenous creatinine clearance = 60 ml/min (Cockcroft-Gault formula); Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = 50%; h. Signed informed consent and compliance is good, and family members agree to cooperate with survival follow-up.

Exclusion Criteria

a. Previous or co-existing malignancies other than basal cell carcinoma of the skin and carcinoma in situ of the cervix, which have been cured; Patients with small gastric stromal tumors, as well as other early tumors after radical treatment, other tumors that do not affect the patient's life in the short term according to the investigators can be excluded; b. Participated in other drug clinical trials within four weeks; c. Patients with known or history of central nervous system metastasis prior to screening. For patients with clinically suspected CNS metastasis, CT or MRI examination must be performed within 28 days before enrollment to rule out CNS metastasis. d. Patients with a history of unstable angina pectoris; Patients with newly diagnosed angina pectoris or myocardial infarction within 3 months prior to screening; Arrhythmias (including QTcF: =450 ms in men and =470 ms in women) requiring long-term use of antiarrhythmic drugs and New York Heart Association grade =II cardiac insufficiency; e. Urine routine indicated urinary protein =++ and confirmed 24-hour urinary protein quantity > 1.0g; f. For female subjects: should be surgically sterilized, postmenopausal, or consent to use a medically approved contraceptive during the study treatment and for 6 months after the end of the study treatment period; Serum or urine pregnancy tests must be negative within 7 days prior to study enrollment and must be non-lactating. Male subjects: patients who should be surgically sterilized or who have consented to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment period; g. Used immunotargeted therapy drugs; h. A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; i. Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and others requiring corticosteroid use; j. History of chronic autoimmune diseases, such as systemic lupus erythematosus; History of ulcerative enteritis, Crohn's disease and other inflammatory bowel diseases, irritable bowel syndrome and other chronic diarrheal diseases; A history of sarcoidosis or tuberculosis; History of active hepatitis B, hepatitis C and HIV infection; k. Patients with hypersensitivity to human or murine monoclonal antibodies; l. Have a history of psychotropic drug abuse and can not quit or have mental disorders; m. pleural effusion or abdominal effusion with clinical symptoms requiring clinical intervention; n. A concomitant disease that, in the investigator's judgment, seriously endangers the patient's safety or interferes with the patient's ability to complete the study.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety;objective response rate;

Secondary Outcome Measures

Name	Time	Method
progressives free survival;overall survival;6 months progression free survival rate;6 months overall survival rate;12 months progression free survival rate;12 months overall survival rate;disease control rate;quality of life;PG-SGA;