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

NCT ID: NCT06413017

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2025-12-31

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

Conditions

HCC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nimtuzumab combined ICIs

Patients will be treated with nimotuzumab combined immune checkpoint inhibitors treatment

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

Nimtuzumab：400mg,i.v.,once a week,until tumor progression、Death or untalerable toxicity

ICIs(Immune checkpoint inhibitors)

Intervention Type: DRUG

Use it as it is describe in the instructions from the specification

Interventions

Nimotuzumab

Nimtuzumab：400mg,i.v.,once a week,until tumor progression、Death or untalerable toxicity

Intervention Type: DRUG

ICIs(Immune checkpoint inhibitors)

Use it as it is describe in the instructions from the specification

Intervention Type: DRUG

Other Intervention Names

h-R3; PD-1 or PD-L1

Eligibility Criteria

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)

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jihui Hao

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jihui Hao, Dr

Role: STUDY_CHAIR

Tianjin Medical University Cancer Institute and Hospital

Locations

Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Chuntao Gao, Dr

Role: CONTACT

gaochuntao@tjmuch.com

022-2340123 ext. 022-2340123

Facility Contacts

Chuntao Gao, MD

Role: primary

gaochuntao@tjmuch.com

022-2340123 ext. 3077

Other Identifiers

Nim-PC-7

Identifier Type: -

Identifier Source: org_study_id