locally advanced progressive EGFR-positive pancreatic cancer
Conditions
Interventions
Experimental group:Becotatug vedotin plus immune checkpoint inhibitor
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Understand the study procedures and content, and voluntarily sign a written informed consent form. 2. Age 18–80 years, inclusive. 3. ECOG Performance Status score of 0–1. 4. Histopathologically confirmed pancreatic adenocarcinoma. 5. Tumor assessed as meeting the CSCO guideline definition of locally advanced disease: (1) Unresectable due to tumor invasion, venous occlusion, or extensive involvement of the jejunal branch of the superior mesenteric vein precluding safe reconstruction of the portal vein–superior mesenteric vein; (2) Pancreatic head/uncinate process tumors: tumor contact with the superior mesenteric artery or celiac axis >180°; pancreatic body/tail tumors: tumor contact with the superior mesenteric artery or celiac axis >180°, or tumor contact with the celiac axis with aortic invasion. 6. Immunohistochemistry confirms high EGFR expression in the subject (IHC 2+/3+, i.e., positive cell proportion >50%). 7. No prior anti-tumor therapy. 8. Adequate organ and bone marrow function, with screening laboratory tests meeting the following criteria: (1) Hemoglobin >=9 g/dL within the past 14 days without transfusion or erythropoietin use; (2) Absolute neutrophil count (ANC) >=1.5 × 10^9/L within the past 14 days without granulocyte colony-stimulating factor use; (3) Platelet count (PLT) >=9 × 10^9/L within the past 14 days without transfusion; (4) Total bilirubin (TBIL) =50 mL/min (by Cockcroft–Gault formula); (7) Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) 3 months. 10. For female subjects of childbearing potential, a urine or serum pregnancy test must be negative within 3 days before the first dose of study drug (Cycle 1 Day 1). If the urine pregnancy test cannot be confirmed as negative, a serum pregnancy test is required. Non-childbearing potential is defined as postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy. 11. If there is a risk of conception, all subjects must use contraceptive methods with a failure rate <1% per year during the entire treatment period and for 120 days after the last dose of study drug. 12. Subjects must agree to provide sufficient tumor tissue samples for EGFR and PD-L1 expression testing, including archived tumor specimens (paraffin blocks or unstained slides meeting the quantity required for the specified assays); if no archived tumor tissue sample is available, the subject agrees to undergo re-biopsy of the tumor lesion.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of another malignant disease within 5 years prior to first dose (excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been completely resected). 2.Prior treatment with an ADC drug containing MMAE as the cytotoxic payload. 3.Currently participating in interventional clinical study treatment, or receipt of other investigational drugs or use of investigational devices within 4 weeks prior to first dose. 4.Major surgery (except biopsy for diagnostic purposes) within 4 weeks prior to first dose of study drug, or anticipation of major surgery during the study period. 5.Severe, unhealed wound, ulcer, or bone fracture. 6.Known allergy to Becotatug Vedotin, gemcitabine, their active ingredients, or excipients. 7.Known history of human immunodeficiency virus (HIV) infection (i.e., HIV-1/2 antibody positive). 8.Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA copy number above the upper limit of normal of the local laboratory). 9.Receipt of a live vaccine within 30 days prior to first dose (Cycle 1, Day 1). 10.Pregnant or lactating women. 11.History or evidence of disease, treatment, or laboratory abnormality that could interfere with the trial results, preclude full participation, or otherwise render the subject unsuitable for enrollment in the opinion of the investigator. Serious or uncontrolled systemic diseases, such as: Clinically significant and poorly controlled abnormalities in rhythm, conduction, or morphology on resting ECG, e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation. Unstable angina, congestive heart failure, chronic heart failure of New York Heart Association (NYHA) class >=2. Any arterial thrombosis, embolism, or ischemic event within 6 months prior to enrollment, e.g., myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. Poorly controlled blood pressure (systolic BP >140 mmHg, diastolic BP >90 mmHg). Active pulmonary tuberculosis. Active or uncontrolled infection requiring systemic therapy. Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction. Liver disease such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis. Urinalysis showing proteinuria >=2+ and confirmed 24-hour urinary protein >1.0 g. 12.Patients with mental disorders that preclude compliance with treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Progression?Free Survival(PFS); | — |
Countries
China
Contacts
Public ContactXiaoyi Wang
Huashan Hospital, Fudan University
Outcome results
None listed