Biliary Tract Cancer
Conditions
Interventions
Intervention Group:Capecitabine + Finolitimab + Bevacizumab
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years, any gender; 2. Participants with biliary tract tumors confirmed by pathological histology or cytology; 3. Have not received systemic treatment drugs outside the protocol prior to randomization; 4. ECOG PS score 0-1; 5. Child-Pugh liver function class A; 6. Postoperative high-risk features of recurrent biliary tract cancer: (1) Tumor diameter >5 cm, or multiple tumors; (2) Presence of vascular invasion, lymph node metastasis, or perineural invasion; (3) Invasion of adjacent tissues or organs; (4) Poorly differentiated; (5) R1 resection margin; 7. If the participant is HBsAg positive, HBV-DNA = 2.5 × 10^9/L); absolute neutrophil count (ANC >= 1.5 × 10^9/L); hemoglobin (Hb >= 9 g/dL); platelet count >= 75 × 10^9/L; (2) Good liver function, defined as: total bilirubin = 60 ml/min; (5) Sufficient pancreatic function, defined as amylase and lipase <= 1.5 × ULN; (6) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal range. Participants with baseline TSH outside the normal range may also be included if total T3 (or FT3) and FT4 are within normal range; (7) Myocardial enzyme profile within normal range; 9. Blood pressure (BP) is adequately controlled with up to three antihypertensive drugs, defined as BP <=150/90 mmHg at screening, and antihypertensive treatment has not changed within one week prior to Day 1/Cycle 1; 10. Not pregnant and no plans to become pregnant; 11. According to imaging examinations (enhanced CT or MRI) and medical history, if the patient shows signs of portal hypertension and severe liver cirrhosis, it is recommended to complete gastroscopy to rule out red signs before enrollment; 12. Study participants voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Mixed-type liver cancer; 2. Patients with other types of tumors; 3. Patients with dysfunction of other major organs; 4. Participation in other clinical trials involving drugs within the past 4 weeks; 5. Known hypersensitivity to the active ingredients or excipients of the study drugs (phenolumab and bevacizumab), or a history of severe allergic reactions to any other monoclonal antibodies or anti-angiogenic targeted drugs; 6. Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to use effective contraception; 7. Patients with grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval >=470ms); NYHA class III–IV heart failure, or echocardiography indicating left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendencies or receiving thrombolytic or anticoagulant therapy; 9. Mental illness or a history of abuse of psychiatric medications; 10. Congenital or acquired immune deficiency (e.g., HIV infection); 11. Known allogeneic organ transplant (except corneal transplant) or allogeneic hematopoietic stem cell transplant; 12. Severe infection within 4 weeks before starting study treatment, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications; use of therapeutic oral or intravenous antibiotics within 2 weeks before starting study treatment (patients receiving prophylactic antibiotics, such as for prevention of urinary tract infection or exacerbation of chronic obstructive pulmonary disease, are eligible for the study); 13. Patients with poor compliance, such as mobile populations; 14. Previous treatment with the following therapies: anti-VEGF2, anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137); 15. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to first dosing. Replacement therapy (e.g., thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic treatment; 16. Receiving systemic glucocorticoid therapy (excluding nasal, inhaled, or other forms of local glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study drug; Note: the use of physiological doses of glucocorticoids (=10 mg/day of prednisone or equivalent) is allowed; 17. Presence of clinically uncontrolled pleural or peritoneal effusion (patients who do not require drainage or whose effusion does not significantly increase within 3 days after drainage can be enrolled); 18. Vaccination with live vaccines within 30 days prior to the first dose of the study drug (Cycle 1, Day 1); Note: inactivated injectable vaccines for seasonal influenza are allowed within 30 days prior to the first dose; however, intranasal live attenuated influenza vaccines are not allowed; 19. History of gastrointestinal bleeding or a definite tendency for gastrointestinal bleeding within 6 months prior to the start of study treatment, or endoscopy showing moderate to severe esophageal or gastric varices with red signs; 20. Occurrence of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, intestinal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;safety and tolereance; | — |
Countries
China
Contacts
Public ContactTianfu Wen
West China Hospital, Sichuan University
Outcome results
None listed