Gastric Cancer, Surgery
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 1 day | 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
| Measure | Time frame | Description |
|---|---|---|
| Median Overall Survival | according to the OS | 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 | 36 months | 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 | 1 day | 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 | 30 days | 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. |
Countries
China