Actively Recruiting
A Phase 2, Open Label, Single-center Study of Lenvatinib and Tislelizumab Combined with Gemcitabine and Cisplatin in the Treatment of Advanced Cholangiocarcinoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-02-10
100
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination treatment using lenvatinib, tislelizumab, gemcitabine, and cisplatin (GPLET) in patients with advanced cholangiocarcinoma, a group of aggressive cancers arising from bile duct cells. This phase 2, open-label study aims to investigate how this combination impacts tumor response and survival compared to gemcitabine plus cisplatin alone. The rationale is based on the potential for these drugs to enhance the immune system's ability to fight cancer by reducing tumor immunosuppression and triggering strong anti-tumor T cell responses. Participants receive intravenous gemcitabine and cisplatin on days 1 and 8 of each 21-day cycle. Those in the experimental group also take oral lenvatinib daily (8 mg if under 60 kg or 12 mg if 60 kg or more) from days 1 to 21, and receive an intravenous dose of tislelizumab on day 15. The control group receives only gemcitabine and cisplatin. Treatment cycles repeat every 21 days, and the study monitors patients through multiple cycles. During the study, participants will undergo evaluations of tumor response after four treatment cycles to measure objective remission rate. Researchers will also track progression-free survival and overall survival for up to 60 months. Safety assessments and regular monitoring of organ and bone marrow function are included. The total study duration allows for long-term follow-up to understand the treatments' impact on disease progression and patient outcomes.
CONDITIONS
Brief Title
Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients.
- World Health Organization (WHO) or ECOG physical state (PS) of 0 or 1.
- At least one measurable target lesion according to RECIST 1.1 criteria.
- No prior immunotherapy including CTLA 4, PD-L1, or PD-1 inhibitors.
- Adequate organ and bone marrow function: hemoglobin 9.0 g/dL or higher, neutrophil count at least 1.5 x 10^9/L, platelet count at least 100 x 10^9/L.
You will not qualify if you...
- Active or previously documented autoimmune or inflammatory disease.
- Uncontrolled medical complications.
- History of other primary cancers.
- Active infection.
- Women who are pregnant or breastfeeding.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 cycles of 21 days each
Participants receive treatment with Lenvatinib, tislelizumab, gemcitabine and cisplatin or gemcitabine and cisplatin chemotherapy.
Visits on days 1, 8, and 15 of each 21-day cycle
Duration - Up to 60 months
Participants are monitored for progression-free survival and overall survival after treatment ends.
Periodic visits for assessments up to 60 months
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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