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

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07314203
Acronym
SOP-XH-IRB
Enrollment
118
Registered
2026-01-02
Start date
2026-12-25
Completion date
2028-08-25
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Surgery

Keywords

gastric cancer, neoadjuvant therapy

Brief summary

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

Interventions

Apatinib Mesylate

Sponsors

Fujian Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

\*\*Inclusion Criteria\*\* 1. Age 18-75 years (inclusive). 2. Histologically or cytologically confirmed unresectable, locally advanced or metastatic HER2-negative adenocarcinoma of the stomach or gastro-oesophageal junction (GEJ). 3\. No prior systemic chemotherapy, radiotherapy, targeted therapy, or immunotherapy for advanced disease. Subjects who have received prior (neo)adjuvant chemotherapy and/or radiotherapy are eligible provided the last dose was completed ≥ 6 months before randomisation. 4\. At least one measurable lesion per RECIST 1.1 (see Appendix 2). 5. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 (see Appendix 4). 6\. Estimated life expectancy \> 3 months. 7. Adequate major organ function defined as: 1. Haematology (obtained ≤ 14 days without transfusion): 1. Hb ≥ 80 g/L 2. WBC ≥ 3 × 10⁹/L 3. ANC ≥ 1.5 × 10⁹/L 4. PLT ≥ 100 × 10⁹/L 2. Biochemistry: 1. Total bilirubin \< 1.5 × upper limit of normal (ULN) 2. ALT and AST \< 2.5 × ULN; ALP ≤ 1.5 × ULN 3. Serum creatinine ≤ 1 × ULN and calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula) 8. Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to enrolment and must use highly effective contraception from screening until 8 weeks after the last dose of study drug. Men must be surgically sterile or agree to use effective contraception during the same period. 9\. No participation in any other interventional clinical trial during the pre-treatment or on-treatment phases of this study. 10\. Voluntary written informed consent obtained; willing and able to comply with study procedures and follow-up.

Design outcomes

Primary

MeasureTime frameDescription
Objective response rate1 dayObjective 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

MeasureTime frameDescription
Median Overall Survivalaccording to the OSMedian 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 Survival36 monthsProgression-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 Response1 dayDuration 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 Event30 daysAdverse 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.

Countries

China

Contacts

Primary ContactChangMing Huang, MD,PhD
hcmlr2002@163.com+8613805069676

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026