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New drug cocktail aims to outsmart untreatable bile duct cancer

NCT ID NCT07691515

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This clinical trial tests a new approach for people with a type of bile duct cancer that cannot be removed by surgery. It compares a combination of targeted therapy and a procedure that delivers chemotherapy directly to the liver against standard chemotherapy. The goal is to see if the new combination helps people live longer and with a better quality of life.

What this could mean

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

Active substance
Tislelizumab, Lenvatinib, Gemcitabine, Cisplatin
What this could lead to
If successful, this could offer a more effective first-line treatment option for people with unresectable intrahepatic cholangiocarcinoma, potentially improving survival and quality of life.
What could go wrong
This is an early-stage Phase 3 trial with a relatively small number of participants. The combination therapy may cause significant side effects, and it is not yet known if it will be better than the standard chemotherapy regimen.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 140 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

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. Age ≥18 years. 2. Histologically confirmed intrahepatic cholangiocarcinoma that is unresectable or recurrent after curative treatment, without extrahepatic metastasis. 3. No prior systemic therapy or transarterial interventional therapy for intrahepatic cholangiocarcinoma. 4. At least one measurable intrahepatic lesion according to RECIST v1.1. 5. ECOG performance status of 0 or 1. 6. Child-Pugh class A liver function. 7. Life expectancy ≥3 months. 8. Adequate hematologic, hepatic, renal, and thyroid function within 14 days before study start, defined as: * Absolute neutrophil count ≥1.5 × 10⁹/L; * Platelet count ≥75 × 10⁹/L; * Hemoglobin ≥90 g/L; * Serum albumin ≥30 g/L; * Total bilirubin ≤1.5 × upper limit of normal; * AST and ALT \<1.5 × upper limit of normal, and ALP \<4 × upper limit of normal; * TSH \<1 × upper limit of normal, with T3 and T4 within the normal range; * Serum creatinine \<1.5 × upper limit of normal and creatinine clearance ≥60 mL/min. Exclusion Criteria: 1. Diffuse infiltrative liver lesions. 2. Contraindications to TACE. 3. Allergy to intravenous contrast agent. 4. pregnant or breastfeeding women, or participants planning pregnancy within 2 years / unwilling to use effective contraception. 5. Patients with HIV or syphilis infection. 6. Patients with concurrent malignancies or other malignancies within 5 years before enrollment. 7. History of allogeneic organ transplantation. 8. Severe dysfunction of the heart, kidney, or other organs. 9. Severe clinically active infection \> grade 2 according to NCI-CTC v5.0. 10. Psychiatric illness that may affect the informed consent process; Inability to take oral medications; Participation in another drug clinical trial within 12 months before enrollment.

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma Cirrhosis, Familial, with Pulmonary Hypertension intrahepatic cholangiocarcinoma

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

    18 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

  • Ganzhou Hospital-Nanfang Hospital, Southern Medical University

    Ganzhou, Jiangxi, 341000, China

  • Guangdong Second People's Hospital

    Guangzhou, Guangdong, 510317, China

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529030, China

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang, 321000, China

  • Jinshazhou Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong, 510168, China

  • Lishui Central Hospital

    Lishui, Zhejiang, 323020, China

  • NingBo Medical Center Lihuili Hospital

    Ningbo, Zhejiang, 315048, China

  • NingBo No.2 Hospital

    Ningbo, Zhejiang, 315010, China

  • The Affiliated Hospital of QingDao University

    Qingdao, Shandong, 266000, China

  • The Affiliated Panyu Central Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 511400, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330209, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510060, China

  • The Second Affiliated Hospital of Guangdong Medical University

    Guangzhou, Guangdong, 524003, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011, China

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013, China

  • West China School of Medicine/West China Hospital, Sichuan University (WCSM/WCH, SCU)

    Chengdu, Sichuan, 610041, China

  • Wuhan Union Hospital of China

    Wuhan, Hubei, 430022, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

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