Actively Recruiting
Combination Therapy of GCNT and Tislelizumab in Advanced Biliary Tract Cancer
Led by CHA University · Updated on 2025-09-15
61
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 with unresectable, locally advanced, or metastatic biliary tract cancers (BTC), including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer. The Phase 1b portion aims to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Nab-paclitaxel in combination with Gemcitabine, Cisplatin, and Tislelizumab. In the Phase 2 portion, the study will evaluate the Objective Response Rate (ORR) as the primary endpoint, with additional assessments of Overall Survival (OS), Progression-Free Survival (PFS), Disease Control Rate (DCR), and Quality of Life (QoL). Safety and tolerability will also be closely monitored. This study seeks to leverage the stromal-disrupting effect of Nab-paclitaxel and the immune checkpoint blockade effect of Tislelizumab, combined with the established chemotherapy backbone of Gemcitabine and Cisplatin, to enhance treatment outcomes for BTC patients. The study will enroll patients across three medical centers in South Korea, including CHA Bundang Medical Center, Haeundae Paik Hospital, and Seoul National University Bundang Hospital.
CONDITIONS
Official Title
Combination Therapy of GCNT and Tislelizumab in Advanced Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer (excluding neuroendocrine tumors, sarcoma, mixed cholangiocarcinoma-HCC, and ampullary carcinoma).
- Age 19 years or older.
- Treatment-nafve for unresectable or metastatic BTC, or recurrence/metastasis occurring at least 6 months after curative surgery or adjuvant chemotherapy.
- Presence of measurable lesions according to RECIST v1.1 criteria.
- ECOG Performance Status of 0 or 1 within 14 days prior to first treatment dose.
- Life expectancy of at least 3 months.
- Adequate organ function within 14 days prior to first dose, including hemoglobin 9.0 g/dL, absolute neutrophil count 1,500/bcL, platelet count 100,000/bcL, serum creatinine 1.5 ULN or creatinine clearance 45 mL/min, AST and ALT 3.0 ULN ( 5.0 ULN if hepatic metastases), total bilirubin 1.5 ULN, INR 1.5 or prothrombin time 1.5 ULN, and aPTT 1.5 ULN.
- Female participants must confirm non-childbearing status or have a negative serum pregnancy test within 7 days before starting treatment.
- Female subjects receiving cisplatin must agree to use effective contraception for 14 months after last dose; male subjects 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 last dose.
- Cardiac function with left ventricular ejection fraction 50%, no serious valvular disorders or arrhythmias, and corrected QT interval 470 msec at screening.
- Willingness to provide tumor tissue samples by biopsy.
You will not qualify if you...
- 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 previous treatments that may affect study evaluation.
- Known allergy to any study drugs (tislelizumab, gemcitabine, cisplatin, nab-paclitaxel).
- Active or past 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 diseases such as peptic ulcer, colitis, or diverticulitis.
- Known central nervous system metastases.
- Uncontrolled tumor-related complications including pericardial or pleural effusion, ascites requiring intervention, or uncontrolled pain.
- Significant cardiovascular conditions including recent myocardial infarction, uncontrolled angina, severe heart failure (NYHA Class III or IV), persistent hypertension despite treatment, arrhythmias needing medical intervention, thrombosis or vascular diseases requiring surgery.
- Uncontrolled diabetes mellitus.
- Active infections requiring treatment within 14 days before first dose.
- Recent treatment with systemic corticosteroids or immunosuppressants within 28 days before first dose.
- Recent antitumor therapy, pleurodesis, or major/minor surgery within specified timeframes before first dose.
- Positive for HIV-1 or HIV-2.
- Active Hepatitis B or C infection except stable cases with low viral load.
- Pregnant or breastfeeding women.
- Use of unapproved drugs within 28 days before enrollment.
- Cognitive impairment preventing informed consent.
- Severe neuropathy (Grade 2).
- Hearing impairment.
- Inability or unwillingness to provide informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea, 13496
Actively Recruiting
Research Team
H
Hong Jae Chon, MD. PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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