New drug cocktail aims to outsmart untreatable bile duct cancer
NCT ID NCT07691515
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- 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 years and older
- 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.
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. 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.
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.
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The places running it
18 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Ganzhou Hospital-Nanfang Hospital, Southern Medical University
Ganzhou, Jiangxi, 341000, China
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Guangdong Second People's Hospital
Guangzhou, Guangdong, 510317, China
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Jiangmen Central Hospital
Jiangmen, Guangdong, 529030, China
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Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 321000, China
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Jinshazhou Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510168, China
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Lishui Central Hospital
Lishui, Zhejiang, 323020, China
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NingBo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315048, China
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NingBo No.2 Hospital
Ningbo, Zhejiang, 315010, China
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The Affiliated Hospital of QingDao University
Qingdao, Shandong, 266000, China
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The Affiliated Panyu Central Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 511400, China
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The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330209, China
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The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
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The Second Affiliated Hospital of Guangdong Medical University
Guangzhou, Guangdong, 524003, China
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The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
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The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
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West China School of Medicine/West China Hospital, Sichuan University (WCSM/WCH, SCU)
Chengdu, Sichuan, 610041, China
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Wuhan Union Hospital of China
Wuhan, Hubei, 430022, China
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a targeted pill shrink hard-to-treat bile duct cancers?
- Can AI be a second pair of eyes for liver cancer detection?
- Spirulina's secret protein may shield the liver during surgery
- AI could spot liver cancer types and predict survival without needle biopsy
- New drug cocktails aim to stop bile duct cancer return after surgery
- New cocktail of Liver-Directed chemo and immunotherapy targets deadly bile duct cancer