Following basal cell carcinoma, Cutaneous Squamous Cell Carcinoma (CSCC) is the most common skin cancer and its incidence remains on a steady rise. The vast majority of CSCC lesions are treated with surgical resection and have a cure rate exceeding 90 percent in early-stage disease. In stark contrast, the 5-year overall survival rate is below 50% for locally advanced patients and less than 10 percent for those with distant metastases. Although the commonly used cisplatin-based combination chemotherapies may achieve an overall response rate of up to 80%, the efficacy is usually not durable. Moreover, the use of chemotherapy is limited due to the many adverse events, especially in elderly patients, who are the largest population of concern for CSCC. The purpose of this study was to assess safety, efficacy in patients with locally advanced or metastatic CSCC given HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
HLX07 1500mg ivgtt Q3W
Nanfang Hospital
Guangzhou, Guangdong, China
RECRUITINGPFS
Progression-free survival by independent radiological review committee (IRRC) assessment per RECIST v1.1
Time frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years
ORR
Objective response rate by IRRC assessment per RECIST v1.1
Time frame: up to 2 years
OS
Overall survival
Time frame: from the date of first dose unitl the date of death from any cause,assessed up to 2 years
DOR
Duration of response
Time frame: from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years
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