New chemo cocktail shows promise against tough bile duct cancer
NCT ID NCT03406299
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two different chemotherapy drug combinations in 92 people with advanced bile duct or gallbladder cancer that could not be removed by surgery. The goal was to see which combination better kept the cancer from growing for at least 6 months. Participants received either the experimental SLOG regimen or the standard gemcitabine plus cisplatin regimen, and researchers tracked tumor response, survival, and side effects.
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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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92 people
The number who actually took part.
- Started
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Apr 2018
- Finished
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Dec 2024
- 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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20 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have histologically confirmed, advanced or metastatic biliary tract carcinoma (including intrahepatic bile duct, hilum bile duct, extrahepatic bile duct and gallbladder), except ampulla vater cancer or combined hepatocholangiocarcinoma. * presence of at least one measurable tumor lesion which is defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥20 mm using conventional techniques or ≥10 mm with spiral CT and MRI; measurable lymph nodes must be≥15 mm in the short axis. * Patients must have no history of prior chemotherapy for Biliary Tract Cancer, except those delivered as adjuvant setting that completed at least 6 months before documentation of recurrence by imaging study. * Patients with prior radiotherapy are eligible if the irradiated area does not involve the only source of measurable / evaluable disease. * Patients' baseline Eastern Cooperative Oncology Group (ECOG)performance status must be less than or equal 1. * Patients' life expectancy must be 12 weeks or greater. * Patients' age must be more than or equal 20 years old. * Patients must have adequate bone marrow function, defined as white blood cell (WBC) count ≥3,500/ul, absolute neutrophil count (ANC) 1,500/ul, and platelet count ≥100,000/ul. * Patients must have adequate liver function and adequate renal function, defined as the following: serum alanine (ALT) 3 times upper normal limit, serum total bilirubin level less than or equal 2.0 mg/dL, and creatinine clearance rate (CCr) ≥ 60 mL/min ((based upon 24-hour urine collection or calculated by Cockcroft-Gault formula). * Patients with biliary obstruction and adequate drainage procedures before enrollment are eligible. * Patients must agree to have indwelling venous catheter implanted. * Women or men of reproductive potential should agree to use an effective contraceptive method. * All patients must be informed of the investigational nature of this study and must sign and give written informed consent. Exclusion Criteria: * Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible 2 weeks after the completion of radiotherapy. * Patients with central nervous system metastasis * Patients with active infection * Pregnant or breast-nursing women * Patients with active cardiopulmonary disease or history of ischemic heart disease * Patients who have peripheral neuropathy \> Grade I of any etiology, presence of grade 2 or above ascites or pleural effusion, or ≥ grade 2 of diarrhea. * Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator. * Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin, or any malignancy remains disease-free for 3 or more years after initial curative treatment * Patients who are under biologic treatment for their malignancy
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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.
Contacts and locations
Locations
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Taiwan Cooperative Oncology Group, National Health Research Institutes
Taipei, Taiwan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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