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NCT Number: NCT07658872

Perioperative Fruquintinib Combined With Sintilimab and SOX for Locally Advanced Gastric or GEJ Adenocarcinoma

The purpose of this clinical trial is to evaluate whether perioperative fruquintinib combined with sintilimab and SOX is effective in treating locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study will also assess the safety profile of this treatment regimen.

Primary Objective:

To determine whether perioperative fruquintinib combined with sintilimab and SOX improves the pathological complete response (pCR) rate compared with sintilimab plus SOX in patients with locally advanced gastric or GEJ adenocarcinoma.

Study Design:

Participants will be randomly assigned to receive either fruquintinib combined with sintilimab and SOX or sintilimab plus SOX to evaluate the potential added benefit of fruquintinib in this setting.

Participation Details:

Participants will receive the assigned treatment (fruquintinib combined with sintilimab and SOX or sintilimab plus SOX) every 21 days for approximately 3 months.

They will visit the clinic once every 3 weeks for evaluations, laboratory tests, and monitoring.

Participants will be asked to keep a daily diary to record any symptoms or side effects experienced during the study.

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Key information

Conditions

Gastric Adenocarcinoma Digestive System Diseases Digestive System Neoplasms Esophagogastric Junction Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-75 years.
  • Histologically confirmed gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Clinically staged as T3-4a N0-3M0 by computed tomography (CT) or magnetic resonance imaging (MRI).
  • Considered eligible for curative resection.
  • No prior antitumor therapy for the current disease.
  • Adequate organ function, including hepatic, renal, and bone marrow function, as per prespecified laboratory criteria.
  • Expected survival of ≥6 months.

Exclusion criteria

  • Known mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumor.
  • Uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥ 90 mmHg despite optimized antihypertensive therapy, or hypertension complicated by acute events (e.g., hypertensive crisis, hypertensive encephalopathy) that cannot be stably controlled.
  • Tumor lesions with a bleeding tendency, including but not limited to: active ulcerative tumor lesions, hematemesis within 2 months prior to informed consent, high risk of major gastrointestinal bleeding as determined by the investigator.
  • History of thromboembolic or arterial/venous vascular events within 6 months prior to enrollment, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism.
  • Gastrointestinal perforation or gastrointestinal obstruction within 6 months prior to enrollment.

Treatment and study plan

fruquintinib + sintilimab + SOX

Drug

Fruquintinib, 4mg po d1-14 q3w, four 3-week cycles were administered; S-1 (administered orally twice daily on days 1-14 of each 21-day cycle, with the daily dose determined by body surface area: <1.25 m², 80 mg/day; ≥1.25 to <1.5 m², 100 mg/day; ≥1.5 m², 120 mg/day), four 3-week cycles were administered.

Oxaliplatin (130 mg/m², administered intravenously on day 1), four 3-week cycles were administered.

Sinitilimab+SOX

Drug

S-1 (administered orally twice daily on days 1-14 of each 21-day cycle, with the daily dose determined by body surface area: <1.25 m², 80 mg/day; ≥1.25 to <1.5 m², 100 mg/day; ≥1.5 m², 120 mg/day), four 3-week cycles were administered.

Oxaliplatin (130 mg/m², administered intravenously on day 1), four 3-week cycles were administered.

Primary outcomes

  1. Total pathological complete response (pCR)

    Time frame: Perioperative

    Total pathological complete response (pCR; ypT0) assessed by investigators, defined as the complete absence of tumor cells in the primary tumor on pathological examination.

Secondary outcomes

  1. Event-free survival (EFS)

    Time frame: Through study completion, an average of 2 years

    Event-free survival (EFS), defined as the time from randomization to the first occurrence of relapse, metastasis, or death from any cause;

  2. TRAEs

    Time frame: Through study completion,an average of 2 years

    Treatment-related adverse events (TRAEs) with potential immunologic etiology were categorized and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) (Version 5.0)

  3. major pathologic response（MPR)

    Time frame: Perioperative

    major pathologic response（MPR) defined as ≤10% residual viable tumor cells in the resected primary tumor specimen after neoadjuvant therapy;

  4. R0 resection

    Time frame: Perioperative

    R0 resection defined as microscopically margin-negative resection

  5. overall survival (OS)

    Time frame: Through study completion,an average of 2 years

    OS defined as the time from randomization to death from any cause;

  6. Expression of Predictive Biomarkers Associated With Treatment Response

    Time frame: Baseline through study completion, an average of 2 years

    Predictive biomarkers including PD-L1 expression, Epstein-Barr virus status, tumor mutational burden, and immune-related biomarkers will be analyzed for association with pathological and radiographic treatment response.

  7. Change in Quality of Life Assessed by EORTC QLQ-C30

    Time frame: Through study completion, an average of 2 years

    Quality of life was assessed using the EORTC QLQ-C30 questionnaires, administered at three time points: within one week before initiation of neoadjuvant therapy, within one week before the fourth neoadjuvant therapy cycle, and at 30 days postoperatively (±3 days)

  8. disease-free survival (DFS)

    Time frame: From date of post-surgery until the date of first occurrence of relapse, metastasis, or date of death from any cause, whichever came first, assessed up to 100 months

    DFS defined as the time from the post-surgery baseline scan to the first occurrence of relapse, metastasis, or death from any cause

  9. Change in Quality of Life Assessed by EORTC QLQ-STO22

    Time frame: Through study completion, an average of 2 years

    Quality of life was assessed using the EORTC QLQ-STO22 questionnaires, administered at three time points: within one week before initiation of neoadjuvant therapy, within one week before the fourth neoadjuvant therapy cycle, and at 30 days postoperatively (±3 days).

Study contacts

Contact information is provided by the study sponsor or research team.

Hongfeng Gou, PhD

CONTACT

[email protected]

+86-18980602292

Wen Nie, Ph.D

CONTACT

[email protected]

+86-02885423297

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Official study title

Perioperative Fruquintinib Combined With Sintilimab and SOX Versus Sintilimab and SOX for Resectable Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma：A Multicenter,Open-label, Randomized Controlled Phase II Clinical Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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