NCT07916844Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
A Prospective, Open-label, Randomized Controlled Clinical Study of Hepatic Arterial Infusion Chemotherapy (HAIC) Versus Capecitabine as Adjuvant Therapy for Biliary Tract Malignancies After Radical Resection
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
This is a prospective, open-label, randomized controlled clinical study. The purpose of this study is to evaluate the efficacy and safety of Hepatic Arterial Infusion Chemotherapy (HAIC) compared with Capecitabine monotherapy as adjuvant therapy for patients with biliary tract cancer after radical resection. Patients with histologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer) who have undergone R0 or R1 resection will be enrolled. A total of approximately 90 eligible patients will be randomized in a 1:1 ratio to receive either HAIC (Oxaliplatin plus 5-Fluorouracil) or Capecitabine. The primary endpoint is Recurrence-Free Survival (RFS). The secondary endpoints include Overall Survival (OS) and safety profiles. This study aims to provide high-level evidence for a more effective adjuvant treatment strategy to reduce recurrence and improve survival for patients with resected biliary tract cancer.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 29 Oct 2026
- Start date
- 30 Nov 2026
- Primary completion date
- 30 Dec 2029
- Lead sponsor
- Zhai Wenlong
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07916844
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 90
- From 30 Nov 2026 to the primary completion date, 30 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Pregnant or lactating.
- Received anti-tumor drug therapy for cholangiocarcinoma before or after surgery.
- Cardiac, pulmonary, or renal insufficiency, severe hepatic insufficiency (Child-Pugh C): (1) severe cardiovascular diseases; (2) severe respiratory diseases; (3) renal disease: chronic renal failure, MDRD ≥ stage III; (4) uncontrolled active infection; (5) ASA > 3; (6) BMI ≥ 35.
- Active gastrointestinal bleeding, ulcer, refractory ascites.
- Uncorrectable hypertension, coagulopathy, or severe portal hypertension.
- Tumor recurrence within 1 month after surgery.
- History of other malignancies.
- Received other investigational drugs within 28 days.
- Deemed unsuitable by the investigator.
- Allergy \& Contraindications: severe allergy to iodine contrast media unmanageable by premedication, or contraindications to angiography.
- Postoperative pathology confirmed non-cholangiocarcinoma.
Who the study is looking for
- Age ≥ 18 years, male or female.
- Histopathologically confirmed biliary tract malignancy (intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, gallbladder cancer, and distal cholangiocarcinoma) and underwent radical surgery with negative surgical margins.
- No history of other tumors, and no prior anti-tumor therapy (including but not limited to chemotherapy, immunotherapy, radiotherapy, targeted therapy, etc.) before or after surgery.
- ECOG performance status: 0~1.
- Baseline blood counts and biochemistry must meet: hemoglobin ≥ 80 g/L; absolute neutrophil count ≥ 1.5 × 10\^9/L; platelet count ≥ 60 × 10\^9/L; ALT/AST ≤ 3 times ULN; total bilirubin ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; albumin ≥ 30 g/L; INR < 1.7 or PT prolonged ≤ 4 seconds.
- Women of childbearing potential must agree to use contraception during the study and for 6 months after; negative pregnancy test within 7 days prior to enrollment; non-lactating. Men must agree to use contraception.
- Patients with active HBV infection must receive anti-HBV therapy starting from screening and willing to continue; HCV RNA positive patients must receive standard antiviral therapy and liver function within CTCAE grade 1 elevation.
- Voluntary participation, signed informed consent, good compliance, willing to cooperate with follow-up.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.