Can targeted chemo infusion outperform pills in biliary tract cancer?
NCT ID NCT07790445
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This trial tests two chemotherapy strategies for people who have had surgery for malignant biliary tract tumors. One group receives hepatic arterial infusion chemotherapy, where drugs are delivered directly to the liver through a catheter. The other group takes capecitabine pills. The study measures how long patients stay free of cancer recurrence after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hepatic arterial infusion chemotherapy (oxaliplatin plus 5-fluorouracil/leucovorin) compared with capecitabine pills
- What this could lead to
- If it works, this could point toward a better way to delay cancer recurrence after surgery for biliary tract tumors.
- What could go wrong
- This is a single-center trial with 90 patients, so results may not apply broadly. Chemotherapy can cause side effects like nausea, low blood counts, and liver or nerve damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- 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. Exclusion Criteria: * 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; Those deemed unsuitable for inclusion by the investigator. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China