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

Last updated: May 10, 2024
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Liver Cancer

Primary Biliary Cholangitis

Digestive System Neoplasms

Treatment

Nimotuzumab

ICIs(Immune checkpoint inhibitors)

Clinical Study ID

NCT06413017
Nim-PC-7
  • Ages 17-79
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with histologically or cytologically confirmed advanced hepatocellularcarcinoma (HCC), or The clinical diagnosis meets the American Association of LiverDiseases (AASLD) diagnostic criteria for hepatocellular carcinoma;

  • Prior experience of targeted, immune, progression after conventional therapy, orintolerance (including TKIs,ICIs, chemotherapy, VEGF monoclonal antibody, or ICIs incombination with TKIs/VEGFs monoclonal antibody/chemotherapy);

  • Child-Pugh liver function rating within 7 days prior to the first dose of studydrug: 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 lesionremained according to mRECIST v1.1;

  • EGFR postive and RAS wildtype;

Exclusion

Exclusion Criteria:

  • Dignosised as hepatic cholangiocarcinoma, mixed cell carcinoma, or fibrolamellarcell carcinoma;

  • History of hepatic encephalopathy within 6 months prior to the first dose of thisstudy;

  • Portal hypertension with endoscopic red signs, or those who are considered by theinvestigator to be at high risk of bleeding or who have had esophageal or gastricvariceal bleeding within 6 months prior to the first dose;

  • Symptomatic brain or meningeal metastases (unless patient is treated> 3 months, noevidence of progression on imaging within 4 weeks prior to treatment, andtumor-related clinical symptoms is stable)

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Nimotuzumab
Phase: 2
Study Start date:
August 31, 2023
Estimated Completion Date:
December 31, 2025

Study 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

Connect with a study center

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin,
    China

    Active - Recruiting

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