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

NCT07790445 | Not Yet Recruiting Phase 4

• 1 other identifier: 2026-KY-0663-002
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Biliary Tract Tumors

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival(PFS)

  From date of randonization until disease progerssion or death, assessad up to 12 months

• Recurrence-free survival (RFS)

  Time from surgery to the first documented recurrence or death from any cause.

  From the date of surgery until the date of first documented recurrence or death from any cause, whichever came first, assessed up to 12 months.

Study Arms (2)

Capecitabine

ACTIVE COMPARATOR

Participants will receive 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 on Days 1 to 14 of each 3-week cycle (d1-14, q3w; i.e., 2 weeks on treatment followed by 1 week off). The treatment cycle is 3 weeks. Treatment will be continued for a total of 8 cycles.

Drug: Capecitabine

HAIC

EXPERIMENTAL

Participants will receive hepatic arterial infusion chemotherapy (HAIC) as follows: Oxaliplatin 40 mg/m2 will be infused over 2 hours on Days 1 to 3 of each cycle, followed by continuous infusion of 5-fluorouracil 800 mg/m2 for 22 hours. The treatment cycle is 4 weeks. Treatment will be continued for 3 to 4 cycles, or until disease progression, unacceptable toxicity, or withdrawal due to other reasons.

Drug: Oxaliplatin + 5-Fluorouracil/Leucovorin

Interventions

Oxaliplatin + 5-Fluorouracil/Leucovorin DRUG

On days 1-3 of each cycle, oxaliplatin 40 mg/m2 will be infused for 2 h, followed by continuous infusion of 5-fluorouracil 800 mg/m2 for a total of 22 h. One cycle lasts 4 weeks. Treatment will continue for 3-4 cycles

HAIC

Capecitabine DRUG

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; i.e., 2 weeks on treatment followed by 1 week off). One treatment cycle lasts 3 weeks, for a total of 8 cycles

Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Age ≥18 years, male or female;
• Pathologically confirmed biliary malignancy (intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, gallbladder cancer, and distal cholangiocarcinoma), and had undergone curative surgery with negative surgical margins;
• No history of other tumors, and no antitumor therapy received before or after surgery (including but not limited to chemotherapy, immunotherapy, radiotherapy, targeted therapy, etc.);
• ECOG: 0-1;
• Baseline blood count tests and blood biochemistry must meet the following criteria: hemoglobin ≥80 g/L; absolute neutrophil count ≥1.5×10\^9/L; platelet count ≥60×10\^9/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN); total bilirubin ≤2 times ULN; serum creatinine ≤1.5 times ULN; albumin ≥30 g/L; INR \<1.7 or PT prolongation not exceeding 4 seconds; serum creatinine less than 1.5 times the upper limit of normal;
• Women of childbearing potential must agree to use contraception during the study and for 6 months after the study ends (e.g., intrauterine device, contraceptive pills, or condoms); a serum or urine pregnancy test must be negative within 7 days before enrollment, and they must not be breastfeeding; male participants must agree to use contraception during the study and for 6 months after the study ends;
• Patients with active hepatitis B virus (HBV) infection must begin anti-HBV treatment during the screening phase and be willing to receive antiviral treatment throughout the study; patients who are hepatitis C virus (HCV) RNA positive must receive antiviral treatment according to standard treatment guidelines and have liver function elevations no higher than CTCAE grade 1.
• Subjects voluntarily join this study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up.

You may not qualify if:

• Pregnancy or lactation;
• Receipt of antitumor drug therapy for cholangiocarcinoma before or after surgery;
• Cardiac, pulmonary, or renal insufficiency, or severe hepatic insufficiency (Child-Pugh class C): severe cardiovascular and cerebrovascular disease (such as myocardial infarction within the past 6 months, unstable angina within the past 1 month, NYHA class III-IV heart failure, uncontrolled arrhythmia, or onset/worsening of congestive heart failure within the past 30 days). Severe respiratory disease (e.g., FEV1 1.8 mg/dL (or \>160 μmol/L). Renal disease: chronic renal failure, MDRD ≥ stage III: GFR1.8 mg/dL (or \>160 μmol/L) Uncontrolled active infection (e.g., severe suppurative cholangitis, sepsis), requiring intravenous antibiotics and hemodynamic instability. ⑤ ASA score \>3; ⑥ BMI ≥35.;
• Active gastrointestinal bleeding, ulcer, or refractory ascites;
• Drug-uncontrolled hypertension, coagulation dysfunction, or severe portal hypertension;
• Tumor recurrence within 1 month after surgery;
• History of other malignant tumors;
• Receipt of other clinical trial drugs within 28 days;
• Allergy and contraindications: severe allergy to iodinated contrast media that cannot be relieved by premedication, or presence of contraindications to angiography.
• Postoperative pathology confirms non-biliary tract carcinoma.

Sponsors & Collaborators

• Zhai Wenlong: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Related Publications (1)

• [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.

  RESULT

MeSH Terms

Interventions

Oxaliplatin; Fluorouracil; Leucovorin; Capecitabine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Wenlong Zhai, MD

CONTACT

+86-371-66862231; ven0371@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Porfessor

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 27, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

CN (1)