Nimotuzumab Combined With ICIs for the Treatment of Advanced Liver Cancer After First Line Treatment Failure

Tianjin Medical University

Status and phase

Enrolling

Phase 2

Conditions

HCC

Treatments

Drug: Nimotuzumab

Drug: ICIs(Immune checkpoint inhibitors)

Study type

Interventional

Funder types

Other

Identifiers

NCT06413017

Nim-PC-7

Details and patient eligibility

About

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

Full 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

Enrollment

30 estimated patients

Sex

All

Ages

17 to 79 years old

Volunteers

No Healthy Volunteers

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)