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New treatment option for Advanced Cholangiocarcinoma
Official title Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
ClinicalTrials.gov ID: NCT05823311
What this study is testing
What is Lenvatinib, tislelizumab, gemcitabine and cisplatin?
Lenvatinib, tislelizumab, gemcitabine and cisplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced cholangiocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Cholangiocarcinoma (CCA) is a heterogeneous group of cancers arising from the epithelial cells of bile ducts. Because of highly aggressive malignancy, most of the patients are diagnosed at an advanced stage and lose the chance to undergo surgery.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients.
- Expected survival period \> 12 weeks.
- The World Health Organization (WHO) / ECOG physical status (PS) was 0 or 1.
- There was at least one target lesion that matched the RECIST 1.1 criteria at baseline.
- Not previously received immunotherapy, including but not limited to CTLA 4, PD-L1 or/and PD-1 inhibitors.
You likely can't join if
- Active or previously documented autoimmune disease or inflammatory disease.
- Uncontrolled complications.
- History of other primary malignancies.
- Active infection.
- Women who are pregnant or breastfeeding.
- Patients with severe allergic history or specific constitution.
See the full eligibility criteria
- Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients.
- Expected survival period \> 12 weeks.
- The World Health Organization (WHO) / ECOG physical status (PS) was 0 or 1.
- There was at least one target lesion that matched the RECIST 1.1 criteria at baseline.
- Not previously received immunotherapy, including but not limited to CTLA 4, PD-L1 or/and PD-1 inhibitors.
- Adequate organ and bone marrow function, defined as follows: Hemoglobin (Hb)≥9.0g/dL; Neutrophils (ANC) ≥ 1.5\ 10\^9/L; Platelet (Pt) ≥ 50\ 10\^9/L; ALT≤2.5×ULN（Normal upper limit); AST≤2.5×ULN.
- Voluntary participation and signing of informed consent.
- Active or previously documented autoimmune disease or inflammatory disease.
- Uncontrolled complications.
- History of other primary malignancies.
- Active infection.
- Women who are pregnant or breastfeeding.
- Patients with severe allergic history or specific constitution.
- Researchers consider it inappropriate to participate in the test.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.