Hepatocellular carcinoma
Conditions
Interventions
TRIPLET group:HAIC plus Camrelizumab and Apatinib
C-A group:Camrelizumab plus Apatinib
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: typical imaging features of hepatocellular carcinoma, elevated AFP or pathological diagnosis of hepatocellular carcinoma; 2: Diagnosed with unresectable BCLC stage B/C HCC assessed by baseline hematological parameters and enhanced CT or MR; 3: At least one evaluable lesion in the liver 4: No previous cell immunotherapy such as CAR-T and CIK 5: At least one post-treatment assessment based on contrast-enhanced CT or contrast-enhanced MR Imaging with target lesions that could be measured according to RECIST 1.1 criteria 6: ECOG PS score 0-2 7: Tumor invasion into the main portal vein, and/or portal vein tumor thrombus involving the main portal vein or the contralateral first grade branch (Vp4), and/or bile duct invasion and/or tumor diameter more than 10cm. 8.TRIPLET therapy: (1) At Least 1 month of apatinib (2) At least 1 dose of camrelizumab (3) The interval between the apatinib and camrelizumab is within 1 month, and at least 1 rounds HAIC performed within 1 month before and after apatinib or camrelizumab treatment (4) The interval between the last other local treatment and combined treatment was more than 3 months. (5) Antiangiogenic agents and immune checkpoint inhibitors were maintained during imaging assessments before and after treatment. 9: C-A group: (1) At Least 1 month of apatinib (2) At least 1 dose of camrelizumab (3) The interval between the apatinib and camrelizumab is within 1 month, and at least 1
Exclusion criteria
Exclusion criteria: (1) severe heart, brain, lung, kidney and other important organ dysfunction, severe infection or other serious concomitant diseases (> grade 2 CTCAE Version 4.03 adverse events); (2) history of immunosuppressive agents or systemic hormone therapy to achieve immunosuppression (prednisone at a dose of >10mg/ day or other therapeutic hormones) during the course of the disease, and continue to use them within 2 weeks before immunotherapy; (3) history of hepatic encephalopathy; (4) history of ascites drainage within the past 3 months, except those with a small amount of ascites on imaging but without clinical symptoms; (5) history of high blood pressure and antihypertensive drug treatment can't obtain good control (systolic blood pressure =140mmHg or diastolic blood pressure =90mmHg); (6) history of uncontrolled cardiac symptoms or diseases, such as: ? Heart failure above NYHA2; ? unstable angina pectoris; (3) myocardial infarction occurred within 1 year; ? clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) Tc > 450 ms (male); QTc > 470 ms (female); (7) history of hereditary or acquired bleeding and thrombophilia (such as hemophilia, coagulation dysfunction, thrombocytopenia, etc.); (8) Urine routine showed urine protein =++ and confirmed 24-hour urine protein >1.0g; (9) to accept treatment patients with active infection, medication before the 7 days with fuo leukocyte acuity 38.5 ?, or baseline period > 15 x 10 ^ 9 / L; (10) history of congenital or acquired immune deficiency (such as HIV infection); (11) history of other malignant tumors in the past 3 years or at the same time; (12) history of a history of organ transplantation; (13) history of live vaccine during treatment; (14) history of other serious diseases (including mental disorders) that may affect the study results according to the investigator's judgment; (15) to form the immune therapy such as DIK, CTLA 4 single resistance to treatment, etc. before and after treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Objective response rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactMeng-xuan Zuo
Sun Yat-sen University Cancer Center
Outcome results
None listed