Adebrelimab Combined with Irinotecan Liposomes, 5-FU, CF ± Lenvatinib As First-line Treatment for Advanced ICC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHarbin Medical University
About this trial
This is a multicenter, open label, randomized, two-arm clinical study to observe and evaluate the efficacy and safety of adebrelimab combined with irinotecan liposomes, 5-fluorouracil, calcium folinate ± lenvatinib as first-line treatment for advanced intrahepatic cholangiocarcinoma (ICC).
Eligibility criteria
Qualifiers
Age: 18 to 75 years old, male or female not limited;
Histologically confirmed unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma with measurable tumor lesions (meeting RECIST 1.1 criteria);
Have not received systemic anti-tumor treatment in the past;
Patients who relapse more than 6 months after curative surgery or after completion of adjuvant therapy (chemotherapy and/or radiotherapy) meet the inclusion criteria;
Disqualifiers
Pregnant or lactating women, or those who have the ability to conceive but refuse to take contraceptive measures;
History of other malignant tumors within the past 5 years, excluding cervical carcinoma in situ or squamous cell carcinoma of the skin that has been adequately treated, or basal cell carcinoma of the skin that has been largely controlled;
Merge other serious uncontrolled diseases (such as individuals with a history of difficult to control mental illness or severe intellectual or cognitive impairment; severe heart failure, angina pectoris, myocardial infarction, arrhythmia, etc.);
Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function;
Trial design
Treatments tested in this trial
- Adebrelimab
- Irinotecan liposomes
- Lenvatinib
- 5-Fluorouracil (5-FU)
- Calcium Folinate
Treatment groups
68 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov