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 range18 Years – 75 Years
SexALL
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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);
✕. 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);
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
✕. 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;