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

NCT07314203 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: SOP-XH-IRB
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Cancer; Surgery

Keywords

gastric cancer; neoadjuvant therapy

Outcome Measures

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).

  1 day

Secondary Outcomes (4)

• Median Overall Survival

  according to the OS

• Progression-Free Survival

  36 months

• Duration of Response

  1 day

• Adverse Event

  30 days

Study Arms (1)

research group

EXPERIMENTAL

Study population received the combination of Adabelimab, Apatinib Mesylate, and SOX regimen

Drug: Apatinib Mesylate Tablets

Interventions

Apatinib Mesylate Tablets DRUG

Apatinib Mesylate

research group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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).
• \. Estimated life expectancy \> 3 months. 7. Adequate major organ function defined as:
• Haematology (obtained ≤ 14 days without transfusion):
• Hb ≥ 80 g/L
• WBC ≥ 3 × 10⁹/L
• ANC ≥ 1.5 × 10⁹/L
• PLT ≥ 100 × 10⁹/L
• Biochemistry:
• Total bilirubin \< 1.5 × upper limit of normal (ULN)
• ALT and AST \< 2.5 × ULN; ALP ≤ 1.5 × ULN
• 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.
• \. No participation in any other interventional clinical trial during the pre-treatment or on-treatment phases of this study.
• \. Voluntary written informed consent obtained; willing and able to comply with study procedures and follow-up.

You may not qualify if:

• Subjects meeting any of the following conditions will be excluded from enrollment:
• 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.
• Prior exposure to: anti-PD-1, anti-PD-L1, anti-PD-L2, or any agent targeting other T-cell co-stimulatory or co-inhibitory pathways (including but not limited to CTLA-4, OX-40, CD137); or prior chemotherapy including S-1.
• Live-vaccine administration within 4 weeks before enrollment or planned during the study.
• Note: Inactivated seasonal influenza vaccine by injection is allowed within 4 weeks; intranasal live-attenuated influenza vaccine is prohibited.
• Active autoimmune disease requiring systemic therapy (e.g., immunosuppressants, corticosteroids, or disease-modifying agents) within 2 years before the first dose. Replacement therapy (thyroxine, insulin, physiologic glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic therapy.
• Prior allogeneic bone-marrow or solid-organ transplantation.
• Any condition that could impair drug absorption or inability to swallow oral medication.
• Uncontrolled hypertension despite optimal medical management:
• SBP ≥ 150 mmHg or DBP ≥ 100 mmHg on a single antihypertensive, or requirement of ≥ 2 antihypertensive agents.
• Urinalysis showing proteinuria ≥ 2+ and 24-h urinary protein \> 1.0 g.
• Active gastro-duodenal ulcer, ulcerative colitis, or other gastrointestinal disorders with bleeding risk; un-resected tumors with active hemorrhage; or any other condition judged by the investigator to predispose to GI bleeding or perforation.

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

ChangMing Huang, MD，PhD

CONTACT

+8613805069676; hcmlr2002@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief doctor, phD, FACS

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start (Estimated): December 25, 2026
• Primary Completion (Estimated): August 25, 2027
• Study Completion (Estimated): August 25, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)