pancreatic cancer
Conditions
Interventions
Comprehensive treatment:terelizumab combined with chemoradiotherapy
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form voluntarily; provide written informed consent before entering the study, and the patient has understood that the Withdraw from the study at any time during the study without any loss. Willing and able to follow the protocol during the study period. 2. Male or female, aged >= 18 years. 3. ECOG/PS physical fitness score 0-1 point. 4. Histologically confirmed pancreatic ductal adenocarcinoma (including cytologically confirmed), clinically classified according to enhanced CT/MRI Stage locally advanced pancreatic cancer that cannot be surgically removed can be included in the group. 5. Have not received chemotherapy or any research drugs for pancreatic cancer. 6. The investigator believes that the patient is suitable to use gemcitabine combined with albumin-bound paclitaxel. 7. According to the RECIST1.1 standard, the patient has at least one evaluable tumor. Imaging tests must be randomized Within the first 14 days. 8. The subjects baseline blood routine and biochemical indicators meet the following standards: hemoglobin >= 100g/L; absolute neutrophils Count (ANC 1.5 x 10^9/L; platelet 100 x 10^9/L ALT, AST 2.5 times the upper limit of normal; ALP 2.5 times the upper limit of normal; serum total bilirubin = 60ml/min/1.73m2; serum albumin 35g/L; international standardized ratio INR) or prothrombin time PT 1.5 times ULN, unless the patient is receiving anticoagulation therapy, and PT value is within the expected therapeutic range of anticoagulants; activated partial thromboplastin time (apT 1.5 times ULN D dimer <= 5 times the upper limit of normal. 9. There are no serious concomitant diseases that make the survival time < 5 years. 10. The patient needs to have a proper nutritional status, BMI greater than 18KG/M2, and body weight greater than 40kg. 11. Patients who need biliary stent implantation must complete biliary stent implantation at least 7 days before screening. 12. Agree to provide histological specimens.
Exclusion criteria
Exclusion criteria: 1. Previously received treatments for pancreatic tumors, including radiotherapy, chemotherapy and immunotherapy. 2. Patients with active autoimmune disease or a history of autoimmune disease but may relapse. 3. There are uncontrollable pleural effusions, pericardial effusions or ascites that require frequent drainage within 14 days before enrollment (the effusion is allowed to be confirmed by cytology), gastrointestinal bleeding, or those with high bleeding risk judged by the investigator. 4. Gastrointestinal perforation and fistula occurred within 6 months before enrollment. 5. Weight loss >= 20% in the 2 months before joining the group. 6. Pulmonary diseases with clinical significance: interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, etc. 7. There are uncontrollable systemic diseases including diabetes, hypertension, etc. 8. Severe chronic or active infections that require systemic antibacterial, antifungal or antiviral therapy, including tuberculosis, HIV infection, etc. 9. Untreated chronic hepatitis B or chronic HBV carriers carrying hepatitis B virus (HBV DNA exceeding 500IU/mL, or hepatitis C virus (HCV RNA positive patients should be excluded. Inactive hepatitis B surface antigen HBsAg) carrying Patients, treated and stable hepatitis B patients with HBV DNA = 2 ventricular arrhythmia occurred within <= 6 months before enrollment, or accompanied by supraventricular tachyarrhythmia requiring medication. f. Cerebrovascular accident (CVA) occurred within 6 months before enrollment. 11. Known peripheral nerve disease NCI CTC AE level 1. However, patients with only the disappearance of deep tendon reflexes (DTR) need not be excluded. 12. Moderate or severe renal impairment The creatinine clearance rate is equal to or lower than 50 ml/min (calculated according to the Cockroft and Gault equation)])], or the upper limit of normal for serum creatinine (ULN). 13. Those who are allergic to any research drug ingredients. 14. Have performed allogeneic stem cell transplantation or organ transplantation. 15. Patients who need systemic treatment with corticosteroids (dose higher than 10 mg/d of prednisone or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days before enrollment. 16. Have received live vaccines within 4 weeks before enrollment. (Remarks: Seasonal influenza vaccines are usually inactivated vaccines and are allowed to be used. Vaccines used in the nasal cavity are live vaccines and are not allowed.) 17. Have received immunotherapy (such as interleukin, interferon, thymosin, etc.) or any experimental treatment within 28 days or 5 half-lives (whichever is shorter, but at least 14 days) before enrollment. 18. Palliative radiotherapy was given within 14 days before enrollment. 19. Have received anti-PD 1, anti-PD L1, anti-PD L2 or any other specific target
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year progression-free Survival Rate at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;PFS;OS;Safey; | — |
Countries
China
Contacts
Public ContactZhou Yuhong
Zhongshan Hospital, Fudan University
Outcome results
None listed