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

NCT06413017 | Recruiting Phase 2

• 1 other identifier: Nim-PC-7
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

HCC

Outcome Measures

Primary Outcomes (1)

• ORR（Objtective reseponse rate）

  （Objtective reseponse rate）

  up to 24 month

Secondary Outcomes (2)

• OS（overall survival）

  up to 24 month

• PFS（pregression free survival）

  up to 24 month

Study Arms (1)

Nimtuzumab combined ICIs

EXPERIMENTAL

Patients will be treated with nimotuzumab combined immune checkpoint inhibitors treatment

Drug: Nimotuzumab; Drug: ICIs(Immune checkpoint inhibitors)

Interventions

Nimotuzumab DRUG

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

Also known as: h-R3

Nimtuzumab combined ICIs

ICIs(Immune checkpoint inhibitors) DRUG

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

Also known as: PD-1 or PD-L1

Nimtuzumab combined ICIs

Eligibility Criteria

• Age: 17 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

RECRUITING

MeSH Terms

Interventions

nimotuzumab; Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Jihui Hao, Dr

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Central Study Contacts

Chuntao Gao, Dr

CONTACT

022-2340123; gaochuntao@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 14, 2024
• Study Start: August 31, 2023
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)