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NCT07658872Not yet recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 22 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
First submitted
31 May 2026
Start date
15 Jun 2026
Primary completion date
19 May 2027
Lead sponsor
Sichuan University
NCT number
NCT07658872

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 120
  • From 15 Jun 2026 to the primary completion date, 19 May 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Other

  • Known mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumor.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.