A Prospective, Open-Label, Randomized Controlled Clinical Study Comparing Hepatic Arterial Infusion Chemotherapy (HAIC) With Capecitabine as Adjuvant Therapy After Radical Surgery for Malignant Biliary Tract Tumors

Summary

3\. Study Design 3.1.1 Study Site and Overall Population Overview This study is a prospective, open-label, randomized controlled clinical trial designed to observe and evaluate the efficacy and safety of hepatic arterial infusion chemotherapy compared with capecitabine in the adjuvant treatment of malignant biliary tract tumors after radical surgery. The study population consists of postoperative patients from the Hepatobiliary Surgery Department of our hospital, who are pathologically confirmed to have malignant biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and other subtypes, and who have completed radical resection (R0 or R1 resection), with postoperative pathology confirming no distant metastasis. Using a computer-generated random sequence, participants will be assigned in a 1:1 ratio to either the hepatic arterial infusion chemotherapy group or the capecitabine group. The study will use recurrence-free survival (RFS) as the primary efficacy endpoint, and plans to enroll approximately 90 patients with malignant biliary tract tumors after radical surgery. After giving informed consent and being screened as eligible, participants will receive the following regimens: Hepatic arterial infusion chemotherapy group: Oxaliplatin 40 mg/m2 will be infused on days 1-3 of each cycle over 2 hours, followed by continuous infusion of 5-fluorouracil 800 mg/m2 over a total of 22 hours. One cycle lasts 4 weeks. Treatment will continue for 3-4 consecutive cycles or until disease progression, intolerable toxicity, or withdrawal for other reasons. Capecitabine group: Capecitabine, 1250 mg/m2, orally, twice daily (once in the morning and once in the evening, equivalent to a total daily dose of 2500 mg/m2), administered from day 1 to day 14 of each 3-week cycle (d1-14, q3w; that is, 2 weeks of continuous treatment followed by 1 week off). One treatment cycle lasts 3 weeks, and a total of 8 cycles will be administered.

Timeline

Start

2026-07-30

Primary completion

2028-12-31

Completion

2028-12-31

Publications

• Results [1] 中华医学会外科学分会胆道外科学组，中国医师协会外科医师分会胆道外科专家工作组. 胆道恶性肿瘤全程规范化管理中国专家共识（2023）[J]. 中华外科杂志,2024,62(6):504-513. [2] 中华医学会外科学分会胆道外科学组，中国医师协会外科医师分会胆道外科专家工作组. 胆道恶性肿瘤转化治疗专家共识（2025）[J]. 中华外科杂志,2025,63(6):453-460. [3] Wirasorn K, Ngamprasertchai T, Khuntikeo N, et al. Adjuvant chemotherapy in resectable cholangiocarcinoma patients[J]. Journal of Gastroenterology and Hepatology,2013,28. [4] Mizuno T, Ebata T, Yokoyama Y, et al. Adjuvant gemcitabine monotherapy for resectable perihilar cholangiocarcinoma with lymph node involvement: a propensity score matching analysis[J]. Surg Today,2017,47(2):182-192. [5] Primrose J N, Fox R P, Palmer D H, et al. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study[J]. The Lancet. Oncology,2019,20(5):663-673. [6] Nakachi K, Ikeda M, Konishi M, et al. Adjuvant S-1 compared with observation in resected biliary tract cancer (JCOG1202, ASCOT): a multicentre, open-label, randomised, controlled, phase 3 trial[J]. Lancet,2023,401(10372):195-203.

Drugs

Indications