Durvalumab Combined With GemCis Neoadjuvant Therapy of Resectable Intrahepatic Cholangiocarcinoma… (NCT05672537) | Clinical Trial Compass
UnknownPhase 2
Durvalumab Combined With GemCis Neoadjuvant Therapy of Resectable Intrahepatic Cholangiocarcinoma With High Recurrence Risk
China70 participantsStarted 2023-01-20
Plain-language summary
This study is a randomized controlled study to evaluate the efficacy and safety of Durvalumab combined with GemCis for neoadjuvant treatment of high recurrence risk ICC
Who can participate
Age range
18 Years – 75 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
. Age ≥ 18, male or female;
. Pathological diagnosis confirmed intrahepatic cholangiocarcinoma, which could be resected surgically; One of the following conditions shall be met:
.1 Single tumor, diameter greater than 5cm (T1b) 2.2 Single tumor with vascular invasion (T2), multiple tumors ≤ 3 2.3 Tumor penetrating visceral peritoneum (T3) or directly invading surrounding organs (T4) 2.4 Suspicious lymph node metastasis in Zone 8, 12 or 13
. Can not received systemic treatment before participating in the study;
. ECOG PS score 0-1;
. The main organs function normally, and there is no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases.
. Laboratory inspection shall meet the following requirements:
. The patient voluntarily participated and signed the informed consent form;
Exclusion criteria
. Patients who received PD-1, PD-L1, PD-L2, CTLA-4 before enrollment, or directly received another stimulatory or co inhibitory T cell receptor (such as CTLA-4, 0X40, CD137);
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
1-year relapse free survival rate
Timeframe: 1-year
Trial details
NCT IDNCT05672537
SponsorTianjin Medical University Cancer Institute and Hospital
. Any other research drugs within 4 weeks before enrollment;
. Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy);
. Congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection;
. Uncontrollable clinical cardiac symptoms or diseases, such as NYHA II and above heart failure unstable angina pectoris, myocardial infarction within one year, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;
. Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first drug administration, or fever of unknown cause\>38.5 ° C occurred during screening/before the first drug administration;
. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
. Live attenuated vaccine shall be inoculated within 4 weeks before the first administration or planned during the study period;