A Prospective, Single-Arm, Phase II Study: PD-L1 Monoclonal Antibody + Chemoradiotherapy as Bridg… (NCT07471165) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Prospective, Single-Arm, Phase II Study: PD-L1 Monoclonal Antibody + Chemoradiotherapy as Bridge Therapy to Liver Transplantation for Locally Advanced Perihilar Cholangiocarcinoma (ACHIEVE-LT)
China25 participantsStarted 2026-03-01
Plain-language summary
This study is a prospective, single-arm, phase II clinical trial designed to evaluate the safety and efficacy of PD-L1 monoclonal antibody combined with chemoradiotherapy as a bridge to liver transplantation in patients with locally advanced unresectable perihilar cholangiocarcinoma (pCCA).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Bile duct invasion: involvement of bilateral secondary bile ducts.
. Portal vein invasion: involvement of unilateral or bilateral branches and the main trunk.
. Hepatic artery invasion: involvement of unilateral or bilateral branches.
. Liver invasion: involvement of liver parenchyma or insufficient residual liver volume.
. Hemoglobin ≥ 90 g/L.
. Absolute neutrophil count ≥ 1.5 × 10\^9/L.
. Platelet count ≥ 100 × 10\^9/L.
. Liver function classified as Child-Pugh A, with total bilirubin ≤ 3 times the upper limit of normal (ULN).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Transplant Completion Rate, TCR
Timeframe: From the date of randomization until the date of first documented disease progression or the date of death from any cause, whichever occurs first, with an assessment period of up to 48 months.
Trial details
NCT IDNCT07471165
SponsorThe First Affiliated Hospital with Nanjing Medical University