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New chemo combo shows promise for deadly bile duct cancer

NCT ID NCT05024513

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested whether adding chemotherapy directly into the liver artery (hepatic arterial infusion) to standard bile duct drainage could help people with advanced perihilar cholangiocarcinoma live longer. The study enrolled 127 adults with inoperable cancer. One group received drainage plus the chemo drugs oxaliplatin and 5-fluorouracil, while the other group received drainage plus supportive care only. The main goal was to see if the chemo combination improved overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oxaliplatin and 5-fluorouracil (chemotherapy drugs given directly into the liver artery)
What this could lead to
If this works, it could offer a new treatment option that extends survival for people with advanced bile duct cancer that cannot be removed by surgery.
What could go wrong
This is a phase 2 trial with 127 participants, so results are still preliminary. The chemotherapy may cause side effects like nausea, low blood counts, or liver problems, and the survival benefit may not be large enough to change standard care.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

127 people

The number who actually took part.

Started

Nov 2021

Finished

Oct 2025

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 to 80 years

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: 1. Locally advanced perihilar cholangiocarcinoma proved by histology or cytology. 2. Locally advanced unresectable perihilar cholangiocarcinoma, decided by hepatobiliary doctor and radiologist. 3. Age from 18 years old to 80 years old. 4. The performance of Eastern Cooperative Oncology Group (ECOG) \<2 5. Child-Pugh A or Child-Pugh B (≤ grade 7). 6. Expectant survival time ≥ 3 months. 7. Baseline blood count test and blood biochemical must meet following criteria: 1. Hemoglobin ≥ 90 g/L; 2. Absolute neutrophil count ≥ 1.5×10\^9/L; 3. Blood platelet count ≥ 100×10\^9/L; 4. Serum creatinine ≤ 1.5 times of ULN; 5. Albumin ≥ 30 g/L 8. Patients sign informed consent. Exclusion Criteria: 1. Allergic to contrast agent. 2. Pregnant or lactational. 3. Allergic to 5-fluorouracil, or have metabolic disorder of 5-fluorouracil. 4. Previous systematic chemotherapy or radiotherapy. 5. Patients with complications such as bile leakage and bleeding after PTCD 6. N2 lymphatic metastasis, extrahepatic metastasis, or coinstantaneous a lot of malignant hydrothorax or ascites. 7. History of organ transplantation. 8. Coinstantaneous infection and need anti-infection therapy. 9. Coinstantaneous peripheral nervous system disorder or with history of obvious mental disorder and central nervous system disorder. 10. Diagnosed other kinds of malignant within 5 years, except for non-melanoma skin cancer and carcinoma in situ of cervix. 11. Without legal capacity. 12. Uncorrectable coagulation disorder. 13. Obvious abnormal in ECG or obvious clinical symptoms of heartdisease, like congestive heart failure (CHF), coronary heart disease with obvious clinical symptoms, unmanageable arrhythmia and hypertension. 14. Severe liver disease (like cirrhosis), renal disease, respiratory disease,unmanageable diabetes or other kinds of systematic disease.

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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.

Contacts and locations

Locations

  • Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and Institute

    Beijing, China

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