pancreatic cancer
Conditions
Interventions
intervention group:stereotactic body radiotherapy sequencing camrelizumab and capecitabine
Sponsors
Sir Run Run Shaw Hospital (SRRSH) Affiliated to the Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to join the study and sign the informed consent; 2. Aged >= 18 years; 3. Patients with locally advanced pancreatic cancer reported by histopathology and confirmed by clinical imaging (stage III according to AJCC Version 8 pancreatic cancer staging system); 4. There is at least one measurable target of SBRT based on RECIST 1.1 criteria; 5. ECOG PS score was 0-1, total bilirubin =1.5 x 10^9/L, peripheral blood platelets >=100 x 10^9/L, serum creatinine = 3 months; 10. Women of childbearing age must have had a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use effective contraception throughout the study period and for 6 months thereafter; 11. Male patients whose partner is a fertile woman should use effective contraception during the trial period and for 3 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Patients who have developed or co-developed other malignancies within the previous 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ; 2. Patients who are on systemic sex hormone therapy (other than those who are on physiological hormone replacement therapy), or who have viral hepatitis and are not on standard treatment, or who have been diagnosed with HIV, or who have active tuberculosis; 3. Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, patients with coagulation disorders, patients with bone marrow suppression); 4. Patients with active infection (requiring drug treatment) or cardiovascular and cerebrovascular diseases that were not well controlled within 1 month prior to enrollment (researchers' judgment); 5. Endoscopy showed direct invasion of gastrointestinal tract; 6. Patients who had untreated gastrointestinal ulcers within 1 month prior to enrollment, or had gastrointestinal perforation or gastrointestinal fistula within 3 months prior to enrollment (except those who had fistula to relieve obstructive jaundice); 7. Pancreatic head cancer with obstructive jaundice, or non-pancreatic head cancer with severe and untreated jaundice; 8. Those who have received anti-tumor vaccine, or received live vaccine within 4 weeks prior to the study drug, or have a live vaccine schedule (except inactivated COVID-19 vaccine, etc.); 9. Patients who had previously received abdominal radiotherapy and whose previous radiotherapy site overlapped with the current radiotherapy field; 10. Patients who had not recovered from previous treatment-related toxicity, or had suffered severe trauma or major surgery in the 4 weeks prior to enrollment in the study, as determined by the investigator; 11. Patients who had participated in clinical trials of other drugs within 6 months before joining or enrolling, or planned to participate in clinical trials other than this study in the near future; 12. Known allergy to the drug in question and previous allergy to monoclonal antibodies; 13. Patients with postoperative recurrence of pancreatic cancer and uncured complications of pancreatic cancer at the time of enrollment; 14. Patients who, in the investigator's judgment, have clinically significant complications or other factors that may force them to discontinue the study (including, but not limited to: Patients with significant organ metastases, or severe jaundice, or who are evaluated by the investigator as being intolerant to treatment, or suffering from other serious medical conditions (including mental illness) requiring treatment, or having a history of alcoholism or substance abuse, or having family or social factors that may affect the safety or compliance of the patient); 15. Vulnerable groups, including patients with mental illness, patients with cognitive impairment, critically ill patients, minors, pregnant patients, illiterates, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-related adverse events and abnormalities in laboratory tests; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions to radiotherapy;Incidence of drug-related adverse events (AEs);Local control rate;Objective response rate (ORR);Disease control rate (DCR);Progression-free survival (PFS);Overall survival OS;Relationship between tumor marker CA19-9 and curative effect; | — |
Countries
China
Contacts
Public ContactSun Xiaonan, Liang Xiao
Sir Run Run Shaw Hospital (SRRSH) Affiliated to the Zhejiang University School of Medicine
Outcome results
None listed