Can targeted chemo infusion outperform pills in biliary tract cancer?

NCT ID NCT07790445

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China