To evaluate the efficacy and safety of nimotuzumab in the treatment of EGFR-amplified advanced pan solid tumors (Lung/Esophageal/Gastric/Pancreatic /Colorectal / Head and neck Cervical).
Nimotuzumab is a EGFR monoclonal antibody. This clinical trial is to study the effect and safety of Nimotuzumab for EGFR-amplified advanced pan solid tumors (Lung/Esophageal/Gastric/Pancreatic /Colorectal / Head and neck Cervical) in the real world. The amplification of the patient's EGFR can be determined by tissue-next-generation sequencing (NGS), Liquid-NGS, or fluorescence in situ hybridization (FISH) . EGFR-amplified status identified in any Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. EGFR-amplified status also was assessed for pathogenicity in each case by MTB.Meanwhile, the molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Nitozumab+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status. In addition, exploring molecular markers that can predict the efficacy of Nimotuzumab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Nitozumab injection 400mg/cycle, every 21 days/cycle, until disease progression, intolerable toxicity or death, or subject decision to withdraw from the study.The molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Nitozumab+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status.
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGPFS2/PFS1
The progression free survival (PFS1) after the most recent treatment before enrollment is defined as the progression of the disease from the most recent treatment before enrollment.The progression free survival period (PFS2) after enrollment is defined as the time from matched targeted therapy or unmatched therapy to disease progression or death.
Time frame: Through study completion, an expected average of 1 year
Objective Response Rate(ORR)
The proportion of patients whose tumor volume is reduced to 30% and can be maintained for more than 4 weeks,Based on RECIST criteria v1.1.
Time frame: Through study completion, an expected average of 1 year
Progression-free Survival(PFS)
The time from the beginning of the patient's treatment to the disease progression or death for any reason.Based on RECIST criteria v1.1.
Time frame: The last subject completes at least 24 weeks of follow-up (or disease progression).
Disease control rate(DCR)
The DCR was defined as SD, PR or CR according to RECIST criteria v1.1.
Time frame: Through study completion,an expected average of 1 year
Overall survival(OS)
The time from the patient receiving treatment to the death of the patient for any reason,OS evaluated according to RECIST v1.1.
Time frame: Through study completion, an expected average of 2 years.
Duration of Response(DOR)
Duration of Response,from the first time the evaluation results meet CR or PR criteria to the observation of PD or death.
Time frame: Through study completion, an expected average of 1 year
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Adverse events(AEs)
Include Treatment emerge adverse events, treatment related adverse events and serious adverse events,AEs evaluated according to NCI-CTCAE v5.0.
Time frame: Through study completion, an expected average of 2 years.
Quality of Life(QoL)
The Quality of Life scale was used to represent patients' satisfaction with quality of life to evaluate the changes in QOL of patients before and after treatment
Time frame: Through study completion, an expected average of 2 years.