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

NCT07658872 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: HUAXI-GC
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Gastric Cancer; neoadjuvant treatment; Fruquintinib

Outcome Measures

Primary Outcomes (1)

• Total pathological complete response (pCR)

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

  Perioperative

Secondary Outcomes (9)

• Event-free survival (EFS)

  Through study completion, an average of 2 years

• TRAEs

  Through study completion,an average of 2 years

• major pathologic response（MPR)

  Perioperative

• R0 resection

  Perioperative

• overall survival (OS)

  Through study completion,an average of 2 years

Study Arms (2)

Fruquintinib + Sintilimab + SOX

EXPERIMENTAL

Drug: fruquintinib + sintilimab + SOX

Sintilimab + SOX

ACTIVE COMPARATOR

Drug: Sinitilimab+SOX

Interventions

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.

Fruquintinib + Sintilimab + SOX

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.

Sintilimab + SOX

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan University: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

HMPL-013; sintilimab

Condition Hierarchy (Ancestors)

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

Study Officials

• Hongfeng Gou, Ph.D

  Gastric Cancer Center, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu 610041, Sichuan, China.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongfeng Gou, PhD

CONTACT

+86-18980602292; gouhongfeng1977@wchscu.cn

Wen Nie, Ph.D

CONTACT

+86-02885423297; wennie1228@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 22, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): May 19, 2027
• Study Completion (Estimated): April 6, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share