Esophageal squamous cell carcinoma (ESCC) is a common malignant tumor worldwide, with particularly high incidence in East Asian regions such as China, and is associated with poor patient prognosis. In recent years, immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1 antibodies) combined with chemotherapy have become the standard first-line treatment for advanced ESCC. Multiple randomized controlled trials have confirmed that this combination significantly improves patient survival compared to chemotherapy alone. However, a subset of patients still exhibit poor response or develop resistance to the immunotherapy-chemotherapy regimen, necessitating the exploration of novel combination strategies to further enhance efficacy. The epidermal growth factor receptor (EGFR) is frequently overexpressed in ESCC and is associated with tumor proliferation, metastasis, and poor prognosis, making it an important therapeutic target. Antibody-drug conjugates (ADCs) targeting EGFR achieve precise tumor killing by conjugating an anti-EGFR antibody to a potent cytotoxic payload. Preclinical studies have demonstrated significant antitumor activity of EGFR ADCs in ESCC models. Mechanistically, anti-EGFR therapy and immune checkpoint inhibitor therapy may exert synergistic effects through several avenues: enhancing tumor antigen presentation, remodeling the tumor microenvironment, and modulating PD-L1 expression. Therefore, this triple combination strategy holds promise for overcoming the limitations of monotherapies and providing a new treatment option for patients with ESCC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
Tislelizumab 200mg IV Q3W + Followed by maintenance treatment for 2 year (Tislelizumab 200 mg IV Q3W for 6 cycles and Tislelizumab 200 mg Q3W for 28 cycles)
2mg/kg or 2.3mg/kg,D1,Q3W, 6 cycles
60mg/㎡, D1, Q3W, 6 cycles
Tislelizumab 200mg IV Q3W + Followed by adjuvant treatment for 1 year (Tislelizumab 200 mg IV Q3W for 3 cycles and Tislelizumab 200 mg Q3W for 14 cycles)
2mg/kg or 2.3mg/kg,D1,Q3W,3 cycles
60mg/㎡ , D1,Q3W, 3 cycles
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Objective Response Rate (ORR)
The Overall Response Rate (ORR): is defined as the proportion of patients who achieved complete response (CR) or partial response (PR) as the best response during the treatment. evaluated by the investigator according to RECIST 1.1 criteria.
Time frame: up to 24 months
Arm A:Disease Control Rate (DCR)
Time frame: up to 24 months
Arm B: Pathological Complete Response (pCR) rate
Time frame: up to 24 months
Arm A: Progression Free Survival (PFS)
Time frame: up to 24 months
Arm A: Overall Survival (OS)
Time frame: up to 48 months
Arm A: Adverse Events (AE)
Assessment of the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to the NCI-CTCAE v5.0 criteria; abnormalities in vital signs and laboratory tests
Time frame: up to 36 months
Arm B:Major Pathological Response (MPR) rate
Time frame: up to 24 months
Arm B: R0 resection rate
Time frame: up to 24 months
Arm B:OS
Time frame: up to 48 months
Arm B:Adverse Events (AE)
Assessment of the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to the NCI-CTCAE v5.0 criteria; abnormalities in vital signs and laboratory tests
Time frame: up to 36 months
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