Duodenal Adenocarcinoma
Conditions
Interventions
Experimental group:Neoadjuvant treatment with cadunilumab
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study and signed the informed consent; 2. No gender limitation, age 18-75 years old; 3. The patient was histologically confirmed as duodenal adenocarcinoma and MSI-H/dMMR was confirmed by biopsy pathology; 4. Initial treatment of stage I-IIIB (limited AJCC TNM stage 8th edition, see Annex 3) duodenal adenocarcinoma that can be resectable by imaging evaluation (enhanced CT or enhanced MRI or endoscopic ultrasound); 5. According to the researchers' diagnosis, segmental bowel resection was not suitable for the lesions; 6. No signs of intestinal obstruction; Or intestinal obstruction has been relieved after proximal gastrointestinal anastomosis surgery; 7. No previous chemotherapy, radiation therapy or immunotherapy; 8. Preoperative CT of chest, abdomen and pelvis excluded distant metastasis; 9. Activity status score: ECOG 0-1; 10. Can swallow pills; 11. Expected survival: >=2 years; 12. Vital organ function meets the following requirements (1) Absolute neutrophil count (ANC) >=1.5×109/L; Platelet >=75×109/L; Hemoglobin >=6g/dL; (2) Liver function: serum albumin >=28/L; Bilirubin =50 ml/min (using Cockcroft-Gault formula; (4) Coagulation function: International Normalized Ratio (INR) <=1.5, Activated partial thromboplastin time (APTT) <=1.5×ULN; 13. Female subjects of childbearing age or male subjects whose partners are women of childbearing age are required to take effective contraceptive measures throughout the treatment period and for 6 months after the treatment period. Evidence of postmenopausal status in female subjects, or negative urine or serum pregnancy test results in premenopausal female subjects.
Exclusion criteria
Exclusion criteria: 1) Patients with any active autoimmune diseases or history of autoimmune diseases (including but not limited to hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or those with asthma who have had a complete response in childhood and do not require any intervention after adulthood can be included; but those with asthma requiring medical intervention with a bronchodilator should be excluded). 2) Having comorbidities requiring chronic therapy with immunosuppressive drugs or systemic or topical corticosteroids at immunosuppressive doses (> 10 mg/day of prednisone or other equivalent steroids). 3) Known or suspected allergy to the study drug or allergic to any study related drug administered. 4) With untreated active brain metastases or meningeal metastases with clinical symptoms. 5) Having severe hypertension that is poorly controlled by drugs(systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg). 6) With history of having any other PD-1 or PD-L1 inhibitors or anti-angiogenic agents. 7) Having arrhythmia that requires anti-arrhythmic therapy (except beta-blockers or digoxin), symptomatic coronary artery diseases or local myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure exceeding NYHA Class II-IV. 8) With genetic or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, splenomegaly) or receiving thrombolytic or anticoagulant therapy. 9) Urine protein >= ++ or 24-hour urine protein excretion >= 1.0 g. 10) With significant clinically significant bleeding symptoms or had a clear bleeding tendency, such as gastrointestinal bleeding, active bleeding, baseline fecal occult blood test (++ or above), or diagnosed with vasculitis, within 3 months prior to enrollment. 11) With arterial or venous thrombotic events within 6 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, and cerebral infarction), deep vein thrombosis, and pulmonary embolism. 12) With other active and clinically significant infections. 13) With a history of HIV infection or active chronic hepatitis B or C (hepatitis B: HBsAg positive and HBV DNA >=104 copies/ml; hepatitis C: HCV Ab positive.); 14) Have participated in other clinical trials of medications within 1 month prior to enrollment. 15) With evidence of distant metastasis outside the pelvic cavity pre-operatively. 16) With history of pelvic or abdominal radiotherapy. 17) With history of other malignancy within the past 5 years, except cured in situ carcinoma of the cervix or basal cell carcinoma of the skin. 18) Having received any anti-infection vaccine (e.g., influenza vaccine, chickenpox vaccine) within 4 weeks prior to enrollment. 19) Known or suspected allergy to the study drug or allergic to any study related drug administered. 20) Patient who has other conditions or factors that could potentially affect the study outcomes or lead to premature termination of the study, such as substance abuse, severe diseases (including psychiatric conditions such as seizures), and other medical, psychological, or social conditions that may compromise patient safety or compliance in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Image measuring the response of a tumor to treatment;Tumor pathological regression grade; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival, DFS;R0 resection rate;Overall survival;Adverse event; | — |
Countries
China
Contacts
Public ContactHaibo Qiu
Sun Yat-sen University Cancer Center
Outcome results
None listed