Gastric AdenocarcinomaPhase 2NCT07658872
Perioperative Fruquintinib Combined With Sintilimab and SOX for Locally Advanced Gastric or GEJ Adenocarcinoma
A Phase 2 study testing fruquintinib + sintilimab + SOX and Sinitilimab+SOX in people with Gastric Adenocarcinoma and Esophagogastric Junction Adenocarcinoma, run by Sichuan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma, Esophagogastric Junction Adenocarcinoma
- What is being tested?
- fruquintinib + sintilimab + SOX and Sinitilimab+SOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 6 Apr 2028
- Phase
- Phase 2
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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:
Read more
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.
- Being tested
- fruquintinib + sintilimab + SOX, Sinitilimab+SOX
- Keywords
- Gastric Cancer, neoadjuvant treatment, Fruquintinib
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fruquintinib + sintilimab + SOXDrug
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+SOXDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib + Sintilimab + SOX | Experimental | Not described Receives: Drug: fruquintinib + sintilimab + SOX |
| Sintilimab + SOX | Active comparator | Not described Receives: Drug: Sinitilimab+SOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperative
Secondary outcomes (9)
Event-free survival (EFS)
Event-free survival (EFS), defined as the time from randomization to the first occurrence of relapse, metastasis, or death from any cause;
Measured: Through study completion, an average of 2 years
TRAEs
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)
Measured: Through study completion,an average of 2 years
major pathologic response（MPR)
major pathologic response（MPR) defined as ≤10% residual viable tumor cells in the resected primary tumor specimen after neoadjuvant therapy;
Measured: Perioperative
R0 resection
R0 resection defined as microscopically margin-negative resection
Measured: Perioperative
overall survival (OS)
OS defined as the time from randomization to death from any cause;
Measured: Through study completion,an average of 2 years
Expression of Predictive Biomarkers Associated With Treatment Response
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.
Measured: Baseline through study completion, an average of 2 years
Change in Quality of Life Assessed by EORTC QLQ-C30
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)
Measured: Through study completion, an average of 2 years
disease-free survival (DFS)
DFS defined as the time from the post-surgery baseline scan to the first occurrence of relapse, metastasis, or death from any cause
Measured: 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
Change in Quality of Life Assessed by EORTC QLQ-STO22
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).
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion19 May 2027 (estimated)
- Study completion6 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Zhang, MD, Sichuan University
- Investigators
- Hongfeng Gou, Ph.D, Principal investigator, Gastric Cancer Center, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu 610041, Sichuan, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658872
- Sponsor's protocol ID
- HUAXI-GC
- Status last verified
- Jun 2026
- First submitted
- 31 May 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) may not be shared due to privacy and confidentiality concerns, legal or ethical restrictions, limitations in data sharing agreements or consent, intellectual property rights, commercial interests, or because of technical and resource constraints related to data anonymization and sharing.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07658872
- Acronym / sponsor ID
- HUAXI-GC
- Keywords
- Gastric Cancer, neoadjuvant treatment, Fruquintinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 19 May 2027 (estimated)
- Study completion
- 6 Apr 2028 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib + Sintilimab + SOX | Experimental | Drug: fruquintinib + sintilimab + SOX |
| Sintilimab + SOX | Active comparator | Drug: Sinitilimab+SOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fruquintinib + sintilimab + SOXFruquintinib, 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 | Fruquintinib + Sintilimab + SOX |
| Sinitilimab+SOXS-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 | Sintilimab + SOX |
Primary outcome
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.
9 secondary outcomes
Event-free survival (EFS)
Time frame: Through study completion, an average of 2 years
TRAEs
Time frame: Through study completion,an average of 2 years
major pathologic response（MPR)
Time frame: Perioperative
R0 resection
Time frame: Perioperative
overall survival (OS)
Time frame: Through study completion,an average of 2 years
Expression of Predictive Biomarkers Associated With Treatment Response
Time frame: Baseline through study completion, an average of 2 years
Change in Quality of Life Assessed by EORTC QLQ-C30
Time frame: Through study completion, an average of 2 years
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
Change in Quality of Life Assessed by EORTC QLQ-STO22
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) may not be shared due to privacy and confidentiality concerns, legal or ethical restrictions, limitations in data sharing agreements or consent, intellectual property rights, commercial interests, or because of technical and resource constraints related to data anonymization and sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongfeng Gou, Ph.D principal investigator
Gastric Cancer Center, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu 610041, Sichuan, China.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fruquintinib + sintilimab + SOX and Sinitilimab+SOX in people with Gastric Adenocarcinoma and Esophagogastric Junction Adenocarcinoma, run by Sichuan University.
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 8 inclusion and 5 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 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Hongfeng Gou, PhD (+86-18980602292, gouhongfeng1977@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total pathological complete response (pCR) (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.