About this trial
Clinical Study on the efficacy and safety of HAIC(GEMOX)and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable Intrahepatic Cholangiocarcinoma with high-risk recurrence factors.
Eligibility criteria
Qualifiers
The patient must sign the informed consent;
Age 18-75 years old, male and female;
ECOG Physical status Score (PS score) 0 or 1;
Patients with ICC who have been pathologically diagnosed (histopathological and/or cytological examination) or clinically diagnosed as having high-risk factors;
Disqualifiers
Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma and other non-cholangiocarcinoma malignant tumor components;
Prior systemic therapy and tumor-related surgical treatment (biliary drainage allowed);Patients who relapse after surgery, have received PD1 antibody, PDL1 antibody or CTLA4 antibody, Lenvatinib, chemotherapy in the past; participated in other clinical trials 30 days before screening
Previous or co-existing malignancies other than adequately treated non-melanin skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma;
Active pulmonary tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year prior to enrollment; Had a history of active tuberculosis infection more than 1 year before enrollment, had not received formal anti-tuberculosis therapy or had active tuberculosis;
Trial design
Treatments tested in this trial
- Adebrelimab
- Lenvatinib
- Gemcitabine
- Oxaliplatin
Treatment groups
Sponsors and collaborators
The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborator