Neoantigen Vaccine Plus Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma After Radical Resection

Exclusion Criteria

• •1. Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma, hilar cholangiocarcinoma, and gallbladder cancer;
• •2. Patients with other active malignant tumors other than intrahepatic cholangiocarcinoma within 5 years or simultaneously. Patients with localized tumors that have been cured, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostatic carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., can be included;
• •3. Currently with interstitial pneumonia or interstitial lung disease, or with a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment in the past, or other possible interferences with the judgment and treatment of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchiolitis), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects with active pneumonia or severe lung function impairment shown by chest CT during screening; active tuberculosis;
• •4. Presence of active autoimmune diseases or a history of autoimmune diseases that may relapse \[including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients controlled only by hormone replacement therapy can be included)\]; patients with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, alopecia, controlled type 1 diabetes mellitus treated with insulin, or patients with asthma who have completely resolved in childhood and require no intervention as adults can be included; patients with asthma requiring bronchodilators for medical intervention cannot be included;
• •5. Within 2 weeks before the start of the study, use of immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose \>10mg/day prednisone or other equivalent glucocorticoids);
• •6. Patients with active infections, with unexplained fever ≥38.5°C within 1 week before the start of the study, or with a baseline white blood cell count \>15×10\^9/L;
• •7. Patients with congenital or acquired immune deficiency (e.g., HIV infection);
• •8. Within 4 weeks before the first dose, received or planned to receive live or attenuated live vaccines during the study;
• •9. Within 6 months before the start of the study, significant clinical bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis, etc. If positive for occult blood in stool at baseline, it can be retested; if still positive after retesting, endoscopy is required;
• •10. Known existing hereditary or acquired bleeding disorders (e.g., hemophilia patients), coagulation disorders, thrombocytopenia, etc.); currently receiving full-dose oral or injected anticoagulants or thrombolytics for therapeutic purposes (prophylactic use of low-dose aspirin is allowed, etc.);
• •11. Within 6 months before the start of the study, arterial thromboembolic events, such as cerebrovascular accidents (including transient ischemic attacks, intracerebral hemorrhage, cerebral infarction), CTCAE grade 3 or higher deep vein thrombosis, pulmonary embolism, etc;
• •12. Uncontrolled heart clinical symptoms or diseases, such as: (1) New York Heart Association (NYHA) standard II or higher heart failure or echocardiography: LVEF (left ventricular ejection fraction) \<50%; (2) unstable angina pectoris; (3) myocardial infarction within 1 year before treatment; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc \>450ms (men); QTc \>470ms (women) (QTc interval calculated using the Fridericia formula: if QTc is abnormal, it can be continuously measured for 3 times at intervals of 2 minutes and the average value is taken);
• •13. Hypertension that cannot be well controlled with antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) (based on the average of blood pressure readings from ≥2 measurements); previous history of hypertensive emergencies or hypertensive encephalopathy is allowed;
• •14. Within 6 months before the start of the study, the occurrence of major vascular diseases (e.g., aortic aneurysms requiring surgical repair or recent peripheral arterial thrombosis);
• •15. Severe, unhealed, or open wounds, as well as active ulcerations or untreated fractures;
• •16. Within 4 weeks before the start of the study, received major surgery treatment (excluding diagnostic procedures) or expect to undergo major surgery during the study period;
• •17. Unable to swallow pills, malabsorption syndrome, or any condition that affects gastrointestinal absorption;
• •18. Within 6 months before the start of the study, experienced intestinal obstruction and/or had clinical signs or symptoms of gastrointestinal obstruction, including incomplete obstruction related to the original disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding. If patients with incomplete obstruction/obstruction syndrome/intestinal obstruction signs/symptoms at the time of initial diagnosis received definitive (surgical) treatment to resolve symptoms, they may be eligible for inclusion in the study;
• •19. Within 2 weeks before the start of the study, the use of strong CYP3A4/CYP2C1 inducers including rifampicin (and its analogues) and St. John's wort, or strong CYP3A4/CYP2C19 inhibitors;
• •20. Subjects who have received other neoantigen vaccines, or are allergic to any chemotherapy drugs, anti-angiogenic targeted drugs, or excipients