Sequential Anti-Angiogenic Therapy After Immunotherapy in Advanced Biliary Tract Cancer

Launched by FIRST AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat advanced biliary tract cancer, which includes cancers of the bile ducts and gallbladder. The researchers want to see if giving patients a type of drug that stops blood vessels from feeding the cancer (called anti-angiogenic therapy) after they first receive immunotherapy can help control the cancer longer before it gets worse. Patients will be randomly placed into two groups: one group will receive standard chemotherapy followed by chemotherapy plus the anti-angiogenic drug if the cancer progresses, while the other group will get chemotherapy combined with immunotherapy first, then the same follow-up treatment if needed.

This study is open to adults aged 18 to 75 who have advanced biliary tract cancer confirmed by tissue testing and who have not yet had immunotherapy or anti-angiogenic drugs. Participants need to be healthy enough to handle treatment and have measurable cancer. During the trial, patients will receive treatment at hospitals in China and will have blood and tissue samples taken to help researchers understand how the treatments work. The main goal is to find out if starting with immunotherapy leads to better results when followed by anti-angiogenic therapy, which could help doctors improve care for people with this challenging cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-75 years at time of enrollment; Histologically or cytologically confirmed advanced or metastatic biliary tract adenocarcinoma (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder carcinoma); Unresectable locally advanced or metastatic disease not amenable to curative treatment; At least one measurable lesion according to RECIST version 1.1 criteria; ECOG Performance Status 0-1; Life expectancy ≥ 12 weeks; No prior systemic chemotherapy, immunotherapy, or anti-angiogenic therapy for advanced disease (adjuvant therapy completed \>6 months prior is allowed); Adequate bone marrow function: ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L; Adequate liver function: Total bilirubin ≤2.5×ULN, ALT and AST ≤3×ULN (or ≤5×ULN if liver metastases present); Adequate renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min; Signed informed consent.
• Exclusion Criteria:
• • Mixed histology tumors or neuroendocrine components; Active central nervous system metastases (treated and stable metastases \>4 weeks allowed); History of other malignancies within 5 years (except adequately treated basal cell carcinoma, squamous cell carcinoma of skin, or carcinoma in situ); Active autoimmune disease requiring systemic treatment; History of severe allergic reactions to monoclonal antibodies or study drug components; Uncontrolled hypertension (\>140/90 mmHg despite medication); Significant cardiovascular disease including unstable angina, myocardial infarction within 6 months, or NYHA Class III-IV heart failure; Active bleeding or bleeding tendency, thrombosis, or use of anticoagulants; Major surgery within 4 weeks or minor surgery within 2 weeks; Active infection requiring systemic treatment; Pregnancy or breastfeeding; HIV infection, active hepatitis B or C infection; Psychiatric illness that would limit compliance with study requirements.