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

HCC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06413017
• Other study ID #: Nim-PC-7
• Status: Recruiting
• Phase: Phase 2
• Start date: August 31, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Chuntao Gao, Dr
• Phone: 022-2340123
• Email: gaochuntao[@]tjmuch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• HCC
• Liver Neoplasms

Intervention

Drug:
• Nimotuzumab
Nimtuzumab:400mg,i.v.,once a week,until tumor progression?Death or untalerable toxicity
• ICIs(Immune checkpoint inhibitors)
Use it as it is describe in the instructions from the specification

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR(Objtective reseponse rate)	(Objtective reseponse rate)	up to 24 month
Secondary	OS(overall survival)	Time from the first dose to death	up to 24 month
Secondary	PFS(pregression free survival)	time form fist dose to tumor progression or death	up to 24 month