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Gastric CancerPhase 3SOP-XH-IRBNCT07314203

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

A Phase 3 study testing Apatinib Mesylate Tablets in people with Gastric Cancer and Surgery, run by Fujian Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer, Surgery
What is being tested?
Apatinib Mesylate Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteChina
Study dates
25 Dec 2026to 25 Aug 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Haematology (obtained ≤ 14 days without transfusion):
  • Hb ≥ 80 g/L
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  • 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.
  • 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.

Who cannot join

  • 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.
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  • 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.
  • Significant bleeding tendency within 3 months before enrollment: overt bleeding > 30 mL, hematemesis, melena, hematochezia; hemoptysis (> 5 mL fresh blood within 4 weeks); or thrombo-embolic event (including stroke/TIA) within 12 months.
  • Clinically significant cardiovascular disease:
  • Acute MI, unstable/severe angina, or CABG within 6 months before enrollment;
  • NYHA class > II congestive heart failure;
  • Ventricular arrhythmia requiring therapy;
  • QTc ≥ 480 ms on baseline ECG.
  • Active or uncontrolled severe infection (≥ CTCAE grade 2).
  • Known HIV infection; clinically significant hepatic disorders:
  • Chronic hepatitis B with active replication (HBV DNA > 1 × 10⁴ copies/mL or > 2000 IU/mL);
  • Hepatitis C with detectable HCV RNA (> 1 × 10³ copies/mL);
  • Other hepatitis or cirrhosis.
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Any condition that, in the opinion of the investigator, would compromise the subject's safety or interfere with study participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

ChangMing Huang, MD，PhD contact

+8613805069676

hcmlr2002@163.com

China1 site

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    ChangMing Huang, MD, +8613805069676, hcmlr2002@163.com

Other trials in China

About this study

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

Being tested
Apatinib Mesylate Tablets
Keywords
gastric cancer, neoadjuvant therapy
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apatinib Mesylate TabletsDrug

    Apatinib Mesylate

Study groups in NCT07314203
Study groupRoleWhat they receive
research groupExperimentalStudy population received the combination of Adabelimab, Apatinib Mesylate, and SOX regimen
Receives: Drug: Apatinib Mesylate Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 1 day

Secondary outcomes (4)

  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.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2026
  2. Study start25 Dec 2026 (estimated)
  3. Primary completion25 Aug 2027 (estimated)
  4. Study completion25 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07314203
Sponsor's protocol ID
SOP-XH-IRB
Acronym
SOP-XH-IRB
Status last verified
Dec 2025
First submitted
18 Dec 2025
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apatinib Mesylate Tablets in people with Gastric Cancer and Surgery, run by Fujian Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ChangMing Huang, MD，PhD (+8613805069676, hcmlr2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07314203.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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