pancreatic cancer
Conditions
Interventions
Single arm:Sintilimab with Irinotecan
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Eligible patients must meet all of the following criteria: 1. Sign a written informed consent before implementing any test related procedures; 2. Aged 18 to 75 years; 3. Histologically or cytologically confirmed pancreatic cancer (arising from the pancreatic ductal epithelium) with locally advanced or metastatic non-resectable pancreatic cancer in the clinical record; 4. The disease progresses after previous treatment with Paclitaxel and/or albumin for locally advanced or metastatic disease stages in Gissi. 5. According to the criteria for evaluating the efficacy of solid tumors (RECIST version 1.1) , at least one radiographic lesion can be measured. 6. ECOG score 0-1; 7. The expected survival time is > 3 months; 8. Adequate organ function, sentence is too long, please supply a shorter sentence. If the baseline Tsh is out of the normal range, subjects with total T3(or FT3) and FT4 in the normal range may also be included; 9) the Myocardial Zymogram is within the normal range (even simple laboratory abnormalities that the researchers judged to be clinically insignificant) ; 9. For Women of Reproductive Age, a negative urine or serum pregnancy test should be performed within 3 days prior to the First Study Drug Administration (Day 1 of Cycle 1) . If the results of the urine pregnancy test can not be confirmed as negative, a blood pregnancy test is required. Women of non-reproductive age are defined as those who have at least one year after menopause, or who have undergone surgical sterilization or hysterectomy; 10. If there is a risk of pregnancy, all subjects (male or female) are required to use contraception with an annual failure rate of less than 1 per cent throughout the treatment period until 120 days after the last study drug is administered (or 180 days after the last chemotherapy drug is administered) .
Exclusion criteria
Exclusion criteria: Participants who met the following criteria were excluded from the study: 1. Past treatment with any checkpoint inhibitor for Pancreatic Cancer: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that target another stimulus or co-suppress t cell receptors (E.G. CTLA-4, OX-40, CD137) ; 2. Severe gastrointestinal problems (including bleeding, infection, inflammation, obstruction, or diarrhea greater than Grade 1) ; 3. Those who had major surgery within 4 weeks prior to screening, or who planned major surgery during the study period; 4. Currently participating in an intervention clinical study, or receiving other research drugs or using research devices within 4 weeks prior to initial administration; 5. Cyp 3 a 4 strong inhibitor, strong inducer or UGT 1 a 1 inhibitor were used; 6. Eating a special diet (E.G. grapefruit) within 48 hours prior to use of the study drug can affect drug absorption, distribution, metabolism, and excretion; 7. Patients with known homozygous Ugt 1 a * 28 Gene; 8. Active autoimmune diseases that require systemic treatment, such as the use of disease-relieving drugs, glucocorticoid or immunosuppressants, occur within 2 years prior to the first administration. Alternative Therapies (such as thyroxine, insulin, or glucocorticoid for Adrenal or pituitary dysfunction) are not considered systemic; 9. The study was receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other route of topical glucocorticoid) or any other form of immunosuppressive therapy within 7 days prior to the First Administration of the drug; Note: Use of a physiological dose of glucocorticoid (<=10 mg/day or equivalent) is permitted; 10. Allograft (other than corneal transplantation) or allogeneic Hematopoietic Stem Cell Transplantation is known; 11. Known to be allergic to the active ingredients or excipients in this study, such as Dilizumab, irinotecan, etc.; 12. Not fully recovered from toxicity and/or complications of any intervention prior to initiation of treatment (i.e. , <=1 or baseline, excluding weakness or alopecia); 13. Known History of human immunodeficiency virus (HIV) infection (I. E. HIV 1/2 antibody positive) ; 14. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA more than the upper limit of the normal value of the laboratory); Note: Hepatitis B subjects who meet the following criteria may also be included: 1) HBV VIRAL LOAD & Lt; 1000 COPY/ML (200iu/ml) before first administration, subjects should be treated with anti-HBV therapy to avoid reactivation of the virus throughout the study period of chemotherapy. 2) for subjects with anti-HBc (+) , HBSAG (-), anti-HBs (-) and HBV viral load (-), no prophylactic anti-HBV therapy is required, but the reactivation of the virus should be closely monitored; 15. Active HCV infected subjects (HCV antibody positive and HCV-rna level higher than the lower limit of detection); 16. Live vaccines are administered within 30 days prior to the first dose (1st Cycle, 1st Day); Note: Inactivated Virus Vaccines for seasonal influenza for injection are allowed within 30 days prior to the first dose, but live attenuated influenza vaccines for intranasal administration are not allowed. 17. A pregnant or lactating woman; 18. Sentence is too long, please supply a shorter sentence. It may interfere with the outcome of the trial, prevent the patient from participating in the study at all times, prevent the patient from participating in t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;PFS;AE/SAE; | — |
Countries
China
Contacts
Public ContactYongkun Sun
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed