HCC
Conditions
Brief summary
This is a phase II, open-label, single-arm clinical study of nimotuzumab in combination with immune checkpoint inhibitors in patients with advanced liver cancer who have failed first-line therapy
Detailed description
This study is a prospective, single-arm study, and plans to include 30 patients with hepatocellular carcinoma who do not respond to first-line therapy with a protoPD-1 (or PD-L1) inhibitor in combination with nimotuzumab in the posterior line, and receive nimotuzumab 400mg, D1, QW in combination with PD-1 (or PD-L1) inhibitor in the later line of treatment until disease progression and intolerable toxicity
Interventions
DRUGNimotuzumab
Nimtuzumab：400mg,i.v.,once a week,until tumor progression、Death or untalerable toxicity
Use it as it is describe in the instructions from the specification
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC), or The clinical diagnosis meets the American Association of Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma； * Prior experience of targeted, immune, progression after conventional therapy, or intolerance (including TKIs,ICIs, chemotherapy, VEGF monoclonal antibody, or ICIs in combination with TKIs/VEGFs monoclonal antibody/chemotherapy)； * Child-Pugh liver function rating within 7 days prior to the first dose of study drug: Grade A or better grade B (≤ 7 points) ; * Phase B or C as assessed by BCLC; or Phase III as assessed by CNLC; * Within 4 weeks prior to the first dose, at least one measurable target lesion remained according to mRECIST v1.1； * EGFR postive and RAS wildtype；
Exclusion criteria
* Dignosised as hepatic cholangiocarcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma； * History of hepatic encephalopathy within 6 months prior to the first dose of this study； * Portal hypertension with endoscopic red signs, or those who are considered by the investigator to be at high risk of bleeding or who have had esophageal or gastric variceal bleeding within 6 months prior to the first dose； * Symptomatic brain or meningeal metastases (unless patient is treated\> 3 months, no evidence of progression on imaging within 4 weeks prior to treatment, and tumor-related clinical symptoms is stable)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR（Objtective reseponse rate） | up to 24 month | （Objtective reseponse rate） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS（overall survival） | up to 24 month | Time from the first dose to death |
| PFS（pregression free survival） | up to 24 month | time form fist dose to tumor progression or death |
Countries
China
Contacts
Primary ContactChuntao Gao, Dr
Outcome results
None listed