Combination therapy for advanced biliary tract cancer
A Multicenter Phase 1b/2 Trial Investigating the Efficacy and Toxicity of the Combination of Gemcitabine, Cisplatin, Nab-Paclitaxel, and Tislelizumab in Treatment Naïve Patients With Unresectable, Locally Advanced, or Metastatic BTC
This study is testing a new combination of treatments for people with advanced biliary tract cancer to see if it is safe and effective.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 61 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | CHA University Academic / other |
| Drugs / interventions | tislelizumab, chemotherapy, immunotherapy, radiation, Durvalumab, Pembrolizumab |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT06893380 on ClinicalTrials.gov |
What this trial studies
This multicenter clinical trial investigates the safety and efficacy of a combination treatment involving Gemcitabine, Cisplatin, Nab-paclitaxel, and Tislelizumab for patients with unresectable, locally advanced, or metastatic biliary tract cancers. The trial consists of a Phase 1b portion to determine the maximum tolerated dose of Nab-paclitaxel, followed by a Phase 2 portion that evaluates the objective response rate as the primary endpoint. Additional assessments will include overall survival, progression-free survival, disease control rate, and quality of life, with a strong focus on safety and tolerability.
Who should consider this trial
Good fit: Ideal candidates include treatment-naïve patients aged 19 and older with histologically confirmed unresectable or metastatic biliary tract cancer.
Not a fit: Patients with neuroendocrine tumors, sarcoma, mixed cholangiocarcinoma-HCC, or ampullary carcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival outcomes for patients with advanced biliary tract cancers.
How similar studies have performed: Previous studies have shown promising results with similar combination therapies in biliary tract cancers, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Histologically confirmed biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer (excluding neuroendocrine tumors, sarcoma, mixed cholangiocarcinoma-HCC, and ampullary carcinoma). * Age ≥ 19 years at the time of signing informed consent. * Treatment-naïve for unresectable or metastatic BTC, or recurrence/metastasis at least 6 months after curative surgery or adjuvant chemotherapy. * Measurable lesions per RECIST v1.1. * ECOG Performance Status (PS) of 0-1 within 14 days prior to the first dose. * Life expectancy of ≥ 3 months. * Adequate organ function (within 14 days prior to the first dose): * Hematologic function: Hemoglobin (Hb) ≥ 9.0 g/dL, Absolute neutrophil count (ANC) ≥ 1,500/μL, Platelet count ≥ 100,000/μL * Renal function: Serum creatinine ≤ 1.5 × ULN or CrCl (Cockcroft-Gault) ≥ 45 mL/min * Hepatic function: AST and ALT ≤ 3.0 × ULN (≤ 5.0 × ULN for hepatic metastases), Total bilirubin ≤ 1.5 × ULN * Coagulation: INR ≤ 1.5 or prothrombin time ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN * Reproductive status: * Female participants must provide proof of non-childbearing status or a negative serum pregnancy test within 7 days before the first dose. * Female subjects receiving cisplatin must agree to effective contraception for 14 months after the last dose; male subjects must agree for 11 months. * Women of childbearing potential and non-sterilized men must use at least two effective contraceptive methods during the study and for 6 months after the last dose. * Cardiac function: * Left ventricular ejection fraction (LVEF) ≥ 50% (by echocardiography or MUGA scan) * No serious valvular disorders or arrhythmias * Corrected QT interval ≤ 470 msec at screening * Willingness to provide tumor tissue samples by biopsy (endoscopic or excisional). Exclusion Criteria * Prior treatment history: * Prior systemic chemotherapy, biological therapy, immunotherapy, or hormone therapy for unresectable or metastatic BTC * Prior adjuvant chemotherapy or radiation therapy within 6 months before recurrence * History of another malignancy within 5 years, except: * Completely resected basal cell carcinoma, stage 1 squamous cell carcinoma, carcinoma in situ, or superficial bladder cancer * Unresolved toxicities from prior treatment that could affect study evaluation * Known hypersensitivity to any study drug (tislelizumab, gemcitabine, cisplatin, nab-paclitaxel) * Active or history of autoimmune disease, except: * Hypothyroidism (on stable hormone therapy), vitiligo, or psoriasis not requiring treatment * History of interstitial lung disease, pulmonary fibrosis, or radiation pneumonitis * Active gastrointestinal disease: * Active peptic ulcer, colitis, or diverticulitis Known central nervous system (CNS) metastasis * Uncontrolled tumor-related complications: Pericardial effusion, pleural effusion, or ascites requiring intervention, Uncontrolled tumor-related pain * Significant cardiovascular conditions: * Myocardial infarction within 180 days before enrollment * Uncontrolled angina within 180 days before enrollment * NYHA Class III or IV congestive heart failure * Persistent hypertension ≥ 150/90 mmHg despite treatment * Arrhythmias requiring medical intervention * Thrombosis or vascular diseases requiring surgery * Uncontrolled diabetes mellitus * Active infections requiring systemic treatment within 14 days before the first dose * Recent treatment history: * Systemic corticosteroids (except prophylactic or short-term use) or immunosuppressants within 28 days before the first dose * Antitumor therapy (cytotoxic, targeted, or immunotherapy) within 28 days before the first dose * Pleurodesis within 28 days before the first dose * Major surgery under general anesthesia within 28 days before the first dose * Local anesthesia or minor surgery within 14 days before the first dose * Radiation therapy within 28 days before the first dose (bone metastasis radiation within 14 days is allowed) * Positive for: * HIV-1 or HIV-2 * Active Hepatitis B or C (except HBV DNA \<500 IU/mL with stable antiviral therapy) * Pregnant or breastfeeding women * Use of unapproved drugs within 28 days before enrollment * Cognitive impairment preventing informed consent * Severe neuropathy (Grade ≥ 2, CTCAE v5.0) * Hearing impairment * Inability or unwillingness to provide informed consent
Where this trial is running
Seongnam-si, Gyeonggi-do
- CHA Bundang Medical Center — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Principal investigator: Hong Jae Chon, MD. PhD — Principal Investigator
- Study coordinator: Hong Jae Chon, MD. PhD
- Email: minidoctor@cha.ac.kr
- Phone: 82-31-780-3928
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.