The efficacy and safety of combination with Disitamab Vedotin and with Tislelizumab and Capecitabine for perioperative treatment of locally advanced gastric cancer with HER2 overexpression.
This study included 40 patients with HER2 overexpression in locally advanced gastric cancer or gastroesophageal junction adenocarcinoma, who received treatment with Disitamab Vedotin combined with Tislelizumab and Capecitabine. The patient has not received any previous anti-tumor systemic therapy. HER2 expression is defined as immunohistochemistry (IHC) as 2+or 3+. Subjects who meet the inclusion criteria but do not meet the exclusion criteria will receive perioperative treatment after enrollment. Perioperative treatment includes neoadjuvant therapy and adjuvant therapy. Subjects will receive Disitamab Vedotin combined with Tislelizumab and Capecitabine for 3 cycles in the neoadjuvant phase and 5 cycles of treatment in the adjuvant phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Subjects will receive Disitamab Vedotin combined with Tislelizumab and Capecitabine for 3 cycles (Q3W) in the neoadjuvant phase and 5 cycles (Q3W) of treatment in the adjuvant phase. 1. Disitamab Vedotin:2.5 mg/kg,Q3W; 2. Tislelizumab:200 mg,Q3W; 3. Capecitabine:1000 mg /m2, PO, bid d1-14, Q3W.
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGXuewei Ding
Tianjin, Tianjin Municipality, China
RECRUITINGPathologic complete remission rate (PCR)
Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.
Time frame: up to 1 years
Objective response rate(ORR)
Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR
Time frame: up to 3 years
Major pathological response rate (MPR)
Major pathological response (MPR) rate is defined as the proportion of participants whose percentage of residual tumor in the stomach and lymph node decreased to \< 10%, as determined by a pathologist
Time frame: up to 1 year
1-3-years event-free survival rate of 3year (EFS)
1-3 years event-free survival (EFS) rate is defined as proportion of participants who have no event, including disease progression, cessation of treatment for any reason, or death after 1-3 years of radical treatment.
Time frame: up to 3 years
1-3 years overall survival (OS) rate
1-3 years overall survival (OS) rate is defined as proportion of participants who survived 1-3 years after radical treatment
Time frame: up to 3 years
Adverse Events(AEs)
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Time frame: up to 3 years
Han Liang, Ph.D
CONTACT
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