About this trial
Exploring the pathological complete response rate (pCR) of locally advanced gastric cancer treated with adebelimab combined or not combined with apatinib mesylate and SOX neoadjuvant therapy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hb ≥ 80 g/L
WBC ≥ 3 × 10⁹/L
ANC ≥ 1.5 × 10⁹/L
PLT ≥ 100 × 10⁹/L
Disqualifiers
Known or suspected hypersensitivity to the investigational drug or any drug of the same class.
Other malignancies within the past 5 years, except adequately treated basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix.
Currently receiving treatment in another interventional clinical trial, or any systemic anti-gastric-cancer therapy within 4 weeks prior to the first dose.
Systemic Chinese patent medicines with anti-tumor indications or immunomodulatory agents (e.g., thymosin, interferon, interleukins; local intrapleural use for effusion control is permitted) received within 2 weeks before the first dose.
Trial design
Single group
Treatments tested in this trial
Apatinib Mesylate Tablets
DrugApatinib Mesylate
Treatment groups
Trial outcomes
Primary outcomes
Objective response rate
Objective Response Rate (ORR) is defined as the proportion of patients with confirmed complete response (CR) or partial response (PR) based on standardized, objective criteria (e.g., RECIST 1.1).
Secondary outcomes
Median Overall Survival
Median Overall Survival (OS) is defined as the time from the date of diagnosis or initiation of treatment to the point at which 50% of patients have died (or reached the study endpoint event), serving as a key indicator for evaluating treatment efficacy and prognosis in chronic diseases such as cancer.
Progression-Free Survival
Progression-Free Survival (PFS) is defined as the time from randomization (or initiation of treatment) to the first documented disease progression (PD) or death from any cause, whichever occurs first
Duration of Response
Duration of Response (DOR) is defined as the time from the first documented complete response (CR) or partial response (PR) until disease progression (PD) or death from any cause, whichever occurs first.
Adverse Event
Adverse Event (AE) Incidence Rate is defined as the proportion of participants in a defined analysis set who experience at least one adverse event during a specified observation period after initiation of an intervention (drug, device, or procedure); it quantifies the frequency of intervention-related risk.
Sponsors and contacts
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