A prospective, single-arm, multicenter clinical study on the efficacy and safety of first-line treatment with Slulimumab combined with Bevacizumab and chemotherapy for primary duodenal adenocarcinoma.
- Conditions
- Primary duodenal adenocarcinoma.
- Registration Number
- ChiCTR2400088997
- Lead Sponsor
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1 Age between 18 and 80 years old;<br>2 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;<br>3 Newly diagnosed with histologically confirmed locally advanced or recurrent, metastatic duodenal adenocarcinoma that is unresectable;<br>4 Clearly have at least one measurable lesion that meets the requirements of the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; if the only lesion is one that has previously been treated locally (radiation, ablation, vascular intervention, etc.), there must be clear radiological evidence of disease progression at that lesion;<br>5 Life expectancy of =6 months;<br>6 Laboratory test results within 7 days prior to the first administration of the study drug must meet the following criteria:<br>Neutrophil count =1.5×10^9/L, platelet count =90×10^9/L, hemoglobin =80 g/L;<br>Serum total bilirubin =1.5×upper limit of normal (ULN); in cases of liver metastasis, serum total bilirubin =3×ULN;<br>In the absence of liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5×ULN; in cases of liver metastasis, ALT and AST =5×ULN;<br>Serum creatinine =1.5×ULN and creatinine clearance =50 mL/min (calculated according to the Cockcroft-Gault formula);<br>Routine urine test shows urinary protein <2+; if urinary protein =2+, the 24-hour urine protein quantification should be <1 g;<br>International normalized ratio (INR) =1.5 and partial thromboplastin time (APTT) =1.5×ULN.<br>7 Female patients of childbearing age or male patients with partners of childbearing age must use effective contraceptive measures from at least 1 month before the first administration of the study drug until 6 months after the last administration of the study drug.<br>8 Have fully understood this study and voluntarily signed the informed consent form.
1 Have undergone anti-cancer treatment in the past;<br>2 Have had other malignant tumors within the past 5 years (except for effectively controlled basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix);<br>3 Have received radical radiotherapy (including radiotherapy to more than 25% of the bone marrow) within 4 weeks prior to the first administration of the study drug; have undergone brachytherapy (such as implantation of radioactive particles) within 60 days prior to the first administration of the study drug; have received palliative radiotherapy for bone metastases within 1 week prior to the first administration of the study drug;<br>4 Have undergone major surgery (defined according to the Regulations on the Clinical Application of Medical Technology implemented on May 1, 2009, as grade 3 and 4 surgeries) within 4 weeks prior to the first administration of the study drug, or have unhealed wounds, ulcers, fractures;<br>5 Currently have uncontrollable malignant pleural effusion, ascites, or pericardial effusion (defined as ineffectively controlled by diuretics or puncture as judged by the investigator);<br>6 Have active gastric and duodenal ulcers, ulcerative colitis, and other gastrointestinal diseases, or active bleeding from an unresected tumor, or other conditions that the investigator judges may cause gastrointestinal bleeding or perforation;<br>7 Have evidence or a history of significant bleeding tendency within 1 month prior to the first administration of the study drug (bleeding >30 mL within 1 month, with hematemesis, melena, or hematochezia), hemoptysis (expectoration of >5 mL of fresh blood within 1 month);<br>8 Have active tuberculosis, are undergoing anti-tuberculosis treatment, or have received anti-tuberculosis treatment within 1 year prior to the first administration of the study drug;<br>9 Have a history of and currently existing pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe impairment of lung function that may interfere with the detection and management of suspected drug-related pulmonary toxicity; radiation pneumonitis in the radiation therapy area is allowed;<br>10 Have a history of clinically significant liver disease, including active viral hepatitis infections [positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), with hepatitis B virus (HBV) DNA >1×10^3 copies/mL or >2000 IU/mL; positive for hepatitis C virus (HCV) antibody and HCV RNA >1×10^3 copies/mL], or other hepatitis, clinically significant moderate to severe cirrhosis;<br>11 Test positive for human immunodeficiency virus (HIV) antibodies;<br>12 Have severe cardiovascular diseases, including:Various clinically significant arrhythmias or conduction abnormalities requiring clinical intervention; Various clinically significant cardiovascular diseases, including acute myocardial infarction within 6 months prior to the first study drug administration, severe or unstable angina, coronary artery bypass surgery, New York Heart Association (NYHA) class III/IV congestive heart failure, treatable ventricular arrhythmias, or left ventricular ejection fraction (LVEF) <50%, etc.;<br>13 Are known to be pregnant or breastfeeding;<br>14 Have a known history of allergy to components related to the study drug;<br>15 Have participated in another interventional clinical study within 4 weeks prior to the first administration of the study drug;<br>16 Currently have any disea
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate, ORR;
- Secondary Outcome Measures
Name Time Method Disease control rate, DCR;Progression-free survival, PFS;Overall survival, OS;Safety;