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New test could tailor chemo for bile duct cancer patients after surgery

NCT ID NCT07156058

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms

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.

    Open the record ↗

  3. 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

    RECRUITING

    Beijing, 100021, China

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