Intrahepatic cholangiocellular carcinoma
Conditions
Interventions
experimental group 1:PD-1 inhibitor combined with Lenvatinib and hepatic artery infusion chemotherapy (GEMOX)
Sponsors
Second People's Hospital of Guangdong Province
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 70 years; 2. Intrahepatic cholangiocarcinoma was histologically confirmed; 3. At least one measurable intrahepatic lesion (according to RECIST1.1 criteria); 4. R0 excision cannot be performed due to extensive vascular and/or biliary tract involvement, multiple lesions, or local lymph node metastasis(R0 resection criteria: According to the American Joint Committee on Cancer AJCC Eighth Edition TNM Staging Criteria, the tumor stage was IIIA or lower); 5. Liver involvement is less than 70%; 6. Child-Pugh, grade A/B; 7. KPS score 90 or higher; 8. No contraindications to HAIC, PD-1 inhibitors or targeted drugs for treatment.
Exclusion criteria
Exclusion criteria: 1. Distant metastasis; 2. Tumor invasion of left and right hepatic ducts or common bile duct; 3.VP4 type portal vein tumor thrombus; 4. Diffuse liver cancer; 5. A history of other malignant tumors; 6. Complicated immune system or endocrine system diseases, or other conditions requiring long-term hormone therapy; 7. Patients who had previously received PD 1 antibody, PDL 1 antibody, or CTLA 4 antibody; 8. Severe cardiopulmonary and renal dysfunction; 9. Active infections requiring systemic treatment; 10. Other factors, as determined by the investigator, that may affect subject safety or trial compliance, such as the Serious illness (e.g., mental illness, etc), serious laboratory test abnormalities, or other social factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Objective Response Rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactXiao Chengjiang
Second People's Hospital of Guangdong Province
Outcome results
None listed