New chemo combo shows promise for deadly bile duct cancer
NCT ID NCT05024513
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
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127 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Oct 2025
- 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 to 80 years
- 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.
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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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can Re-Assessing bile duct cancer treatment open the door to surgery?
- Burning away bile duct blockages: a new weapon against cholangiocarcinoma?
- Can a Pre-Surgery drug combo boost bile duct cancer survival?
- Can blood tests reveal how liver and bile duct cancers respond to treatment?
- Can a One-Two punch of heat and drainage tame inoperable bile duct cancer?
- Heat therapy before stenting may extend bile duct patency in cancer patients