Neoadjuvant Gemcitabine and Cisplatin in Combination With Perioperative Pembrolizumab Versus Upfr… (NCT06923475) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Neoadjuvant Gemcitabine and Cisplatin in Combination With Perioperative Pembrolizumab Versus Upfront Surgery for Patients With Primary Resectable and Borderline Resectable Perihilar and Distal Cholangiocarcinoma
Netherlands150 participantsStarted 2025-05-05
Plain-language summary
Extrahepatic cholangiocarcinoma (eCCA) is a rare and aggressive cancer with poor prognosis. ECCA can be further subcategorised in perihilar and distal cholangiocarcinoma (pCCA and dCCA). Surgical resection is the only potential cure, but only one-third of patients are eligible. Even among those deemed resectable, a significant portion (≈30%) experience disease progression before surgery, while another 30% are found unresectable during exploration. High recurrence rates and postoperative complications further limit survival, with 5-year overall survival ranging from 13% (R1 resection) to 40% (R0 resection). Given the long preoperative work-up period and lack of treatment during this phase, a neoadjuvant approach may improve outcomes by increasing R0 resections, reducing recurrence, and optimizing patient selection.
This multicenter, randomized phase 2B/3 trial aims to assess whether neoadjuvant gemcitabine and cisplatin plus perioperative pembrolizumab improves event-free survival in patients with resectable and borderline resectable pCCA and dCCA.
Who can participate
Age range
18 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:
* Histologically or cytologically confirmed resectable or borderline resectable pCCA and dCCA. These are all the patients considered candidates for upfront surgical exploration, with intent to resect, as confirmed by local MDT and the study expert panel also taking into consideration endoscopic and radiological findings. In cases where drainage is not required, patients with a disease highly suspicious for extrahepatic cholangiocarcinoma, as determined by the expert MDT, may be included without histological proof to prevent unnecessary post-ERCP complications.
* Successful drainage, in case of clinical significant bile duct obstruction.
* MidCCA inclusion in the NEODISCO-trial will be permitted and will be included according to the proposed type of resection.
* Male/female participants who are at least 18 years of age on the day of signing informed consent.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
Exclusion Criteria:
* Upfront "clearly" unresectable pCCA: circumferential unreconstructable vascular involvement of the FLR and/or insufficient FLR for potential radical resection. Insufficient FLR is defined as \<30% residual volume or a function \<2.7 min/m2. Patients considered borderline resectable but, by the discretion of the MDT, not a candidate for upfront exploration/resection, are considered ineligible for NEODI…
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.
1This trial compares giving gemcitabine, cisplatin, and pembrolizumab before surgery versus going straight to surgery — given my specific tumor and overall health, does my doctor think I'm likely to benefit more from shrinking the tumor first or from operating as soon as possible?
2Since this is a Phase 2/3 trial and the main thing being measured is 'event free survival,' what does that mean practically for me, and how much is already known about whether adding pembrolizumab to chemotherapy before surgery is safe for cholangiocarcinoma patients?
3Pembrolizumab is an immunotherapy drug that can sometimes cause serious immune-related side effects — given my other health conditions, are there any reasons my doctor would be concerned about me receiving it alongside gemcitabine and cisplatin before a major operation?
4The trial isn't recruiting yet — if I'm interested in this kind of approach, is there a similar active trial nearby, or should I plan to revisit this one once enrollment opens, and how does timing affect my treatment options right now?
5My tumor is classified as resectable or borderline resectable — does my doctor think my specific classification would affect whether the neoadjuvant chemotherapy-plus-immunotherapy approach in this trial makes more sense than upfront surgery followed by standard treatment?
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.