Nimotuzumab and immune checkpoint inhibitors for 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 study is testing if a new combination of nimotuzumab and immune checkpoint inhibitors can help people with advanced liver cancer who didn't respond to their first treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 17 Years to 79 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: chemotherapy, nimotuzumab
• Locations: 1 site (Tianjin)
• Trial ID: NCT06413017 on ClinicalTrials.gov

What this trial studies

This phase II, open-label, single-arm clinical study investigates the efficacy of nimotuzumab combined with immune checkpoint inhibitors in patients with advanced hepatocellular carcinoma (HCC) who have not responded to first-line therapy. The study aims to enroll 30 patients who will receive nimotuzumab at a dosage of 400mg weekly in conjunction with a PD-1 or PD-L1 inhibitor until disease progression or intolerable toxicity occurs. The goal is to evaluate the treatment's effectiveness in this challenging patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with advanced hepatocellular carcinoma who have failed first-line therapy and meet specific eligibility criteria regarding liver function and tumor characteristics.

Not a fit: Patients with hepatic cholangiocarcinoma or those who have experienced hepatic encephalopathy within the last six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could provide a new therapeutic option for patients with advanced liver cancer who have exhausted first-line treatment options.

How similar studies have performed: While this approach is novel in the context of combining nimotuzumab with immune checkpoint inhibitors for advanced liver cancer, similar studies have shown promise in other cancer types.

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)

Where this trial is running

Tianjin

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Chuntao Gao, Dr

Conditions HCC