Vebotolimab Combined With Ptorlimab for EGFR-positive Refractory Advanced Biliary Tract Malignancies

Inclusion Criteria

• •1. Age 18 - 70 years old, gender not restricted;
• •2. Patients with untreated primary advanced biliary system malignancies diagnosed by pathological histology or cytology;
• •3. Physical condition: ECOG PS score 0 - 1;
• •4. Pathological laboratory assessment: EGFR IHC ≥ 1+;
• •5. Have undergone at least one line of systemic drug treatment;
• •6. According to the RECIST 1.1 standard, at least one measurable target lesion that can be detected by CT or MRI;
• •7. Laboratory test indicators meet the following requirements:
• •① Bone marrow function: Hemoglobin (Hb) ≥ 90g/L; White blood cell count (WBC) ≥ lower limit of normal value; Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L; Platelet count ≥ 100×10\^9/L;
• •② Renal function: Cr ≤ UNL (upper limit of normal) × 1.5, endogenous creatinine clearance rate (Ccr) ≥ 55 ml/min;
• •③ Liver function: Total bilirubin ≤ ULN × 1.5; ALT and AST ≤ ULN × 2.5; (if it is intrahepatic cholangiocarcinoma or there is liver metastasis, total bilirubin not higher than 3 times the upper limit of normal, transaminase not higher than 5 times the upper limit of normal);
• •④ Coagulation function: International normalized ratio of prothrombin time ≤ ULN × 1.5, and partial thromboplastin time within the normal range;
• •8. Pregnant women agree to use contraception during the study period and within 6 months after the study ends; The serum or urine pregnancy test is negative within 7 days before the study entry, and non-lactating patients; Male patients agree to use contraception during the study period and within 6 months after the study ends;
• •9. Within 4 weeks before entry, have not participated in other drug clinical trials;
• •10. The subject can understand the situation of this study and voluntarily sign the informed consent form.
• •11. No severe complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever \> 38℃;
• •12. Expected good compliance, able to follow the protocol requirements for efficacy and adverse reactions follow-up.
• •13. Expected survival period \> 3 months.