Clinical Efficacy of Adebrelimab With or Without Apatinib Mesilate and SOX Neoadjuvant Therapy in Locally Advanced Gastric Cancer

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Medical University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Apatinib Mesylate Tablets

    Drug

    Apatinib Mesylate

Treatment groups

118 Participants
are divided into 1 treatment group
Group A: research groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
1 day

Secondary outcomes

1

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.

Time frame
according to the OS
2

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

Time frame
36 months
3

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.

Time frame
1 day
4

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.

Time frame
30 days

Other outcomes

Sponsors and contacts

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