New test could tailor chemo for bile duct cancer patients after surgery
NCT ID NCT07156058
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study is testing whether a quick lab test called MiniPDX can help doctors choose the best chemotherapy drugs for people with bile duct cancer after surgery. The test measures how sensitive a patient's tumor cells are to different drugs in just 7 days. Researchers will follow 204 participants to see if this personalized approach improves how long they stay cancer-free compared to standard treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- capecitabine, gemcitabine, cisplatin, oxaliplatin, 5-FU
- What this could lead to
- If successful, this could show that using a rapid drug sensitivity test helps choose more effective chemotherapy after surgery, potentially delaying cancer return.
- What could go wrong
- This is an early-stage, non-randomized study with no control group, so results may not prove the test improves outcomes. The test itself may not accurately predict drug response in all patients.
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
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 204 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2023
- Expected to finish
-
Dec 2025
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 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: 1. histologically documented biliary duct cancer (including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma and gallbladder carcinoma). Patients underwent R0 resection. 2. Ambulatory male or female. Age ≥ 18 years. 3. ECOG performance status between 0 and 2 4. Patients must be tolerated with combination treatment with life expectancy of greater than 6 months. 5. No dysfunction and bleeding tendency in main organs (heart, liver, brain and kidneys); No history of blood disease; No cardiac insufficiency or chest pain (medically uncontrollable). No myocardial infarction occurred within 12 months before the start of the study. 6. Subjects must have normal organ as defined below: Hb ≥80 g/L; ANC ≥1.5×109/L; Platelets ≥100×109/L; AL/AST ≤2.5 x institutional upper limit of normal; ALP ≤2.5 x ULN; Total bilirubin \<1.5 x ULN; Creatinine \<1 x ULN; Serum albumin ≥30g/L. 7. Women of child-bearing potential must agree to use adequate contraception (IUD, contraceptives or condoms) for the duration of study participation, and for 6 months after completion of study; Serum or urine pregnancy tests are negative within 7 days before study entry; men must agree to use adequate contraception for the duration of study participation, and for 6 months after completion of study. 8. Patients must be willing to and able to follow the protocol during study entry. 9. Patients must be willing to sign an informed consent and able to understand that anytime is all right to quit the study without loss. Exclusion Criteria: 1. Prior chemotherapy or radiotherapy. 2. Patients are in other clinical trials. 3. Coagulation disorders, history of blood disease or serious (active) heart disease such as coronary heart disease with apparent symptom, congestive heart failure of NYHA Class II or more severe, serious heart rhythm controlled by medicaments, or the attack of myocardial infarction within 12 months. 4. Hepatic and renal insufficiency with apparent symptom. 5. Pregnant or lactating female, or women of child-bearing age who have a positive serum pregnancy test or no tests. Female subjects of non-reproductive potential with post-menopausal for ≥1 year. 6. Patients with multiple primary cancer, or brain or meningeal metastases. 7. Patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder whose clinical severity, as judged by the investigator, may hinder the signing of informed consent or affect the patient's compliance with oral medication 8. Patients who need immunotherapy for organ transplantation. 9. Patients with recurrent infections, or other uncontrolled accompanying diseases, or hepatic cirrhosis caused hepatic injury or chronic active hepatitis (ALT ≥2 ULN, AST ≥1.5 ULN, PT \>13 S or TB ≥2 ULN) 10. Moderate or severe kidney injury \[CrCl ≤50 ml/min (Cockcroft-Gault Equation)\], or creatinine \> ULN
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Biliary tract cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
RECRUITINGBeijing, 100021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Second try: pumping chemo straight into the liver for tumors that outsmarted standard treatment
- Immunotherapy meets chemo: a new front against bile duct cancer
- Can a Three-Drug chemo cocktail before surgery stop biliary tract cancer from coming back?
- Can a new drug shrink advanced solid tumors?
- Can adding immunotherapy to standard cancer care be safe for indian patients?
- App-based symptom tracking may cut hospital visits for advanced cancer patients