New cocktail of drugs shows promise for tough bile duct cancer
NCT ID NCT05668884
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing a combination of four drugs—two chemotherapy drugs (gemcitabine and oxaliplatin), a targeted therapy (donafenib), and an immunotherapy (tislelizumab)—in 93 people with advanced biliary tract cancer that has spread. The goal is to see if this mix can shrink tumors and improve survival. Participants must be in fairly good health and have measurable tumors. The study is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Gemcitabine, Oxaliplatin, Donafenib, and Tislelizumab
- What this could lead to
- If successful, this combination could offer a new treatment option that shrinks tumors and delays cancer progression in people with advanced biliary tract cancer.
- What could go wrong
- This is an early phase 2 trial with only 93 participants, so results may not apply to everyone. The combination of four drugs may cause significant side effects, and it is not yet known if it works better than standard treatments.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 93 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Mar 2027
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 to 75 years
- 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: * Age ≥18 years and ≤75 years; * ECOG physical condition score: 0\~1; * Histologically or cytologically confirmed advanced biliary tract carcinoma (including gallbladder, intrahepatic and extrahepatic cholangiocarcinoma); * Preoperative imaging assessment of the disease stage was III/IV; * At least one measurable lesion (according to mRECIST criteria) * Child-Pugh classification : A or B * The main organs function well, and the examination indicators meet the following requirements: * Routine blood tests: Hemoglobin ≥90 g/L (no blood transfusion within 14 days);Neutrophil count ≥1.5×10\^9/L; Platelet count ≥80×10\^9/L; * Biochemical examination: Total bilirubin ≤2×ULN (upper normal value); ALT or AST ≤ 2.5×ULN; Endogenous creatinine clearance ≥ 50 mL /min (Cockcroft-Gault formula); * thyroid function:Thyroid function is normal, thyroid stimulating hormone TSH is defined to be within the normal range. If baseline TSH is outside the normal range, T3 and T4 can be included if they are within the normal range; * Myocardial enzyme profile:The myocardial enzyme profile was in the normal range (if simple laboratory abnormalities that were not clinically significant as determined by the investigators could also be included); * Estimated survival time ≥ 3 months; * Sign the informed consent voluntarily; * Good compliance, and family members willing to cooperate with follow-up. Exclusion Criteria: * Patients with other uncured malignant tumors; * Pregnant or lactating women who are required to withdraw from the clinical trial if they become pregnant during the study period; * Previous antitumor therapy for the disease in this study; * Participated in clinical trials of other drugs within one month; * Patients with a known history of other systemic serious diseases before screening; * Obstructive jaundice (after active treatment such as biliary drainage or stent, the patients can be included in the group after the liver function returns to normal); * Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number greater than the upper limit of normal in the clinical laboratory of the study center); * Active HCV infected persons (HCV antibody positive with HCV RNA levels above the lower limit of detection); * Allergic to any investigational drug or excipient; * Long-term unhealed wounds or incomplete healing fractures; * Previous organ transplantation history; * Having a history of abuse of psychotropic substances and being unable to quit or having mental disorders; * A history of immune deficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; * Concomitant conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study.
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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
1 site. 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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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200062, China
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