Bile duct cancer trial halted after just one patient

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1\. Age: 18-80 years, regardless of gender; 2. Diagnosis of intrahepatic cholangiocarcinoma or perihilar cholangiocarcinoma confirmed by pathological tissue/cytological diagnosis; 3. Meeting the criteria for surgical resection; 4. Presence of high-risk recurrence factors: iCCA (single mass \>5cm, or multiple lesions, or accompanied by satellite lesions, or accompanied by portal vein/hepatic vein invasion, or CA199 \>200U/ml); pCCA (invasion of secondary branches of the bile duct, or invasion of portal vein/hepatic artery, or accompanied by intrahepatic metastasis); 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1; 6. Child-Pugh class A; 7. Normal major organ function, meeting the following standards: 1. Blood routine examination: A. Hb≥90 g/L; B. ANC≥1.5×10\^9/L; C. PLT≥75×10\^9/L; 2. Biochemical examination: A. ALB ≥30g/L; B. ALT and AST\<5×ULN; C. TBiL ≤2×ULN; D. Creatinine ≤1.5×ULN; (3) Coagulation function: A. International normalized ratio (INR) ≤1.5×ULN; B. Activated partial thromboplastin time (APTT) ≤1.5×ULN. 8. Subjects voluntarily join this study, sign informed consent, have good compliance, and cooperate with follow-up. Exclusion Criteria: 1. Regional multiple lymph node metastases or fusion, retroperitoneal lymph node metastases; 2. Peritoneal metastasis, distant metastasis; 3. Previous systemic treatment, including but not limited to chemotherapy, targeted therapy, immunotherapy; 4. Previous local treatment, including but not limited to HAIC, TACE, TARE, ablation, radiotherapy, etc.; 5. Severe hepatic artery variation; 6. Allergy to contrast agents; 7. Allergy to oxaliplatin; 8. Vaccination with live attenuated vaccine within 4 weeks prior to first administration or planned during the study period; 9. Presence of \> grade 1 peripheral neuropathy; 10. Presence of any active autoimmune disease or history of autoimmune disease; 11. Complication of other malignancies (except for basal cell or squamous cell skin cancer or cervical carcinoma in situ that was treated curatively); 12. Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS); 13. Within 6 months prior to entering the study, occurrences of the following: myocardial infarction, severe/unstable angina, NYHA class II heart failure or above, poorly controlled arrhythmias (including QTcF interval male \>450 ms, female \>470 ms, QTcF interval calculated using the Fridericia formula), symptomatic congestive heart failure; 14. Hypertension that cannot be well controlled with antihypertensive medications (systolic blood pressure ≥140 mmHg or diastolic pressure ≥90 mmHg); 15. Abnormal coagulation function (INR\>1.5 or APTT\>1.5×ULN), with bleeding tendency or currently undergoing thrombolytic therapy, anticoagulant therapy, or antiplatelet therapy; 16. Known hereditary or acquired bleeding and thrombosis tendencies, such as hemophilia, coagulation function disorders, thrombocytopenia, splenomegaly, etc.; 17. Significant hemoptysis occurring within 2 months before entering the study, or daily sputum blood volume reaching half a teaspoon (2.5 ml) or more; 18. Patients at risk of gastrointestinal bleeding, including: (1) Presence of active peptic ulcer lesions; (2) History of melena or hematemesis within the past 3 months; (3) For stool occult blood (+) or (+/-), need to retest stool routine within 1 week; if still (+) or (+/-), esophagogastroduodenoscopy is needed; if ulcers or bleeding diseases are present and considered to have potential bleeding risks by the treating physician; 19. Thrombotic events occurring within 6 months prior to entering the study, such as cerebrovascular accidents (including transient ischemic attacks, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 20. Infections requiring drug intervention occurring within 4 weeks prior to first medication (such as requiring intravenous antibiotics, antifungal or antiviral medications), or fever of unknown origin \>38.5°C during screening/ prior to first medication; 21. Participation in any other drug clinical trials within 4 weeks prior to first administration; 22. Known history of substance abuse or drug addiction; 23. Presence of other serious physical or mental diseases or abnormal laboratory tests that may increase the risk of participation in the study or interfere with study results, and patients deemed unsuitable for participation in this study by the investigator.