This is a phase III, Multicenter, Randomized study, evaluating the efficacy and Safety of LM-108(an Anti-CCR8 mAb) in combination With Toripalimab Versus Paclitaxel Injection in subjects with CCR8-Positive locally advanced or metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
LM-108 combined with Toripalimab administered intravenously on Day 1 every 3 weeks
Paclitaxel injection administered at a dose of 80 mg/m² on Day 1, 8, and 15 every 4 weeks
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Overall survival (OS)
OS was defined as the time from date of randomization until death from any cause
Time frame: up to 42 months
Progression Free Survival (PFS)
PFS was defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on Investigator assessment
Time frame: up to 42 months
Objective response rate (ORR)
ORR is defined as the proportion of subjects achieving the best overall response (BOR) of CR or PR. BOR refers to the best response recorded during the period from the date of randomization to the date of objective progression documented according to RECIST 1.1 criteria or the date of initiation of subsequent antitumor therapy (whichever occurs first).
Time frame: up to 42 months
Duration of response (DOR)
defined time from the initial response (CR or PR) until documented tumor progression or death from any cause and based on Investigator assessment.
Time frame: Time from initial response (CR or PR) to date of documented disease progression or death (due to any cause) whichever occurs first, up to 42 months
Disease control rate (DCR)
defined as the proportion of participants who achieved CR, PR, or stable disease (SD) , based on Investigator assessment.
Time frame: From start of treatment to date of documented disease progression, up to approximately 42 months
Incidence of adverse events (AEs)
Time frame: up to 42 months
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