Status:
RECRUITING
Combination Therapy of GCNT and Tislelizumab in Advanced Biliary Tract Cancer
Lead Sponsor:
CHA University
Conditions:
Locally Advanced Biliary Tract Cancers
Metastatic Biliary Tract Cancers
Eligibility:
All Genders
19+ years
Brief Summary
This is a multicenter Phase 1b/2 clinical trial investigating the efficacy and safety of a combination regimen of Gemcitabine, Cisplatin, Nab-paclitaxel, and Tislelizumab in treatment-naïve patients w...
Detailed Description
Biliary tract cancer (BTC) is a heterogeneous group of malignancies arising from the biliary epithelium, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder can...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT06893380
Start Date
October 1 2024
End Date
December 31 2026
Last Update
September 15 2025
Active Locations (1)
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1
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea, 13496