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

Nimotuzumab Combined With Immune Checkpoint Inhibitors for the Treatment of Advanced Liver Cancer After First Line Treatment Failure ，a Prospective， Open Label，Single Arm，Phase II Trail

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

Study Overview

• Status: Recruiting
• Conditions: HCC
• Intervention / Treatment: Drug: Nimotuzumab; Drug: ICIs(Immune checkpoint inhibitors)

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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chuntao Gao, Dr; Phone Number: 022-2340123 022-2340123; Email: gaochuntao@tjmuch.com

Study Locations

• China
  • Tianjin, China
    • Recruiting
    • Tianjin Medical University Cancer Institute and Hospital
    • Contact: Chuntao Gao, MD; Phone Number: 3077 022-2340123; Email: gaochuntao@tjmuch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nimtuzumab combined ICIs; Patients will be treated with nimotuzumab combined immune checkpoint inhibitors treatment	Drug: Nimotuzumab; Nimtuzumab：400mg,i.v.,once a week,until tumor progression、Death or untalerable toxicity; Other Names: h-R3; Drug: ICIs(Immune checkpoint inhibitors); Use it as it is describe in the instructions from the specification; Other Names: PD-1 or PD-L1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR（Objtective reseponse rate）	（Objtective reseponse rate）	up to 24 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS（overall survival）	Time from the first dose to death	up to 24 month
PFS（pregression free survival）	time form fist dose to tumor progression or death	up to 24 month

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Study Chair: Jihui Hao, Dr, Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nimotuzumab
• Other Study ID Numbers: Nim-PC-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No