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Trial Title:
Nimotuzumab Combined With ICIs for the Treatment of Advanced Liver Cancer After First Line Treatment Failure
NCT ID:
NCT06413017
Condition:
HCC
Conditions: Official terms:
Liver Neoplasms
Nimotuzumab
Immune Checkpoint Inhibitors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Nimotuzumab
Description:
Nimtuzumab：400mg,i.v.,once a week,until tumor progression、Death or untalerable toxicity
Arm group label:
Nimtuzumab combined ICIs
Other name:
h-R3
Intervention type:
Drug
Intervention name:
ICIs(Immune checkpoint inhibitors)
Description:
Use it as it is describe in the instructions from the specification
Arm group label:
Nimtuzumab combined ICIs
Other name:
PD-1 or PD-L1
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
Criteria for 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)
Gender:
All
Minimum age:
17 Years
Maximum age:
79 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Chuntao Gao, MD
Phone:
022-2340123
Phone ext:
3077
Email:
gaochuntao@tjmuch.com
Start date:
August 31, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06413017
