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Could alternating chemo drugs boost survival in biliary cancer?

NCT ID NCT07062536

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether alternating between two chemotherapy regimens (mFOLFOX and mFOLFIRI) works better than using just one (mFOLFOX) as a second-line treatment for advanced biliary tract cancer. The study will enroll 130 adults whose cancer has progressed after first-line treatment. The main goal is to see if the alternating approach improves 6-month survival rates.

What this could mean

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

Active substance
chemotherapy drugs (oxaliplatin, 5FU, leucovorin, irinotecan)
What this could lead to
If successful, this could offer a more effective second-line chemotherapy option for people with advanced biliary tract cancer, potentially improving survival.
What could go wrong
This is a phase 2 trial with only 130 participants, so results are preliminary. Chemotherapy has significant side effects, and the alternating regimen may not prove better than standard treatment.

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

About 130 people

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

Started

Aug 2025

Expected to finish

Apr 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

19 to 99 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 (All eligibility criteria must be fulfilled) 1. Age ≥ 19 years. 2. Diagnosed with biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, or ampulla of Vater cancer. 3. Either unresectable advanced disease or recurrence after curative surgery. 4. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 5. First-Line Treatment Failure: Disease progression after at least one cycle of gemcitabine/cisplatin-based therapy or discontinuation of therapy due to adverse effects. 6. Presence of evaluable or measurable lesions according to RECIST v1.1 criteria. 7. Laboratory Criteria: optima bone marrow, liver, and kidney function within one week prior to enrollment: A. Hemoglobin \> 9.0 g/dL B. Absolute neutrophil count (ANC) \> 1,000/uL C. Platelet count \> 75,000/uL D. Serum creatinine \< 1.5× upper limit of normal (ULN) E. AST/ALT \< 3× ULN F. Total bilirubin \< 1.5× ULN (biliary drainage is allowed). 8. Patients who understand the study protocol, can provide written informed consent, and are aware of their right to withdraw at any time without penalty. 9. Effective Contraception (for patients of childbearing potential receiving oxaliplatin): A. Male patients: Must use effective contraception during the study and for 12 months after treatment completion. B. Female patients: Must use effective contraception during the study and for 15 months after treatment completion. \*Exclusion Criteria (Patients meeting any of the following criteria will be excluded from the study.) 1. Patients with prior exposure to oxaliplatin or irinotecan in previous cancer treatments. 2. Patients with metastatic or unresectable biliary tract cancer who have received second- line or higher chemotherapy. 3. Pregnant or breastfeeding women. 4. Patients with a history of other malignancies within the past 3 years, except for papillary or follicular thyroid cancer. 5. Patients with uncontrolled infections or other systemic diseases. 6. Patients with a history of myocardial infarction, unstable angina, or heart failure (NYHA 7. Class III-IV) within the last 6 months. 8. Patients with Grade 3 or higher peripheral neuropathy caused by prior chemotherapy. 9. Patients with known allergic reactions to the investigational drugs. 10. Known patients with Gilbert's syndrome, DPD (dihydro-pyrimidine dehydrogenase) deficiency, or Homozygous UGT1A1\*28 alleles. 11. Patients currently taking potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin), or potent CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John's Wort). 12. Patients who are eligible for targeted therapy, including FGFR inhibitors or IDH1 inhibitors. (eligible for patient who unable to use these targeted agents due to drug cost.) 13. Patients with active CNS metastases and/or carcinomatous meningitis. 14. Patients who meet contraindications for the investigational drugs as per domestic regulatory guidelines, including patients with infections, Interstitial pneumonitis or pulmonary fibrosis, Severe diarrhea, Chronic inflammatory bowel disease, Intestinal paralysis or obstruction, Functional impairment due to peripheral sensory neuropathy, Severe renal dysfunction. 15. Patients deemed ineligible by the investigator for any other reason.

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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

    11 sites. 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

  • Asan Medical Center

    RECRUITING

    Seoul, Seoul, 05505, South Korea

  • CHA Bundang Medical Center

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13496, South Korea

  • Chonnam National University Hwasun Hospital

    RECRUITING

    Hwasun, Jeollanam-do, 58128, South Korea

  • Chungbuk National University Hospital

    RECRUITING

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Dong-A University Hospital

    RECRUITING

    Busan, Busan, 49201, South Korea

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, Incheon, 21565, South Korea

  • Gangneung Asan Hospital

    RECRUITING

    Gangneung, Gangwon-do, 25457, South Korea

  • Keimyung University Dongsan Hospital

    RECRUITING

    Daegu, Daegu, 42601, South Korea

  • Seoul Metropolitan Government Seoul National University Boramae MedicalCenter

    RECRUITING

    Seoul, Seoul, 07061, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Out of US, 13605, South Korea

  • Yonsei University Health System, Severance Hospital

    RECRUITING

    Seoul, Seoul, 03722, South Korea

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