Clinical trial NCT06413017: Nimotuzumab Combined With ICIs for the Treatment of Advanced Liver Cancer After First Line Treatment Failure
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: HCC
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 30
Sex: ALL
Minimum age (years): 17
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

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)

Primary outcomes:
measure: ORR（Objtective reseponse rate）
timeFrame: up to 24 month
Secondary outcomes:
measure: OS（overall survival）
timeFrame: up to 24 month
measure: PFS（pregression free survival）
timeFrame: up to 24 month
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Jihui Hao, Dr
role: STUDY_CHAIR
References: