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

NCT07658872 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-06-22

No results posted yet for this study

Summary

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.

Conditions

  • Gastric Adenocarcinoma
  • Esophagogastric Junction Adenocarcinoma

Interventions

DRUG

fruquintinib + sintilimab + SOX

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.

DRUG

Sinitilimab+SOX

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.

Sponsors & Collaborators

  • Sichuan University

    lead OTHER

Principal Investigators

  • Hongfeng Gou, Ph.D · Gastric Cancer Center, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu 610041, Sichuan, China.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2027-05-19
Completion
2028-04-06

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07658872 on ClinicalTrials.gov