Gastric CancerPhase 2HuaxiNCT07374250

Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) for Locally Advanced Gastric or GEJ Adenocarcinoma

A Phase 2 study testing Ivonescimab (20mg/kg Q3W), Oxaliplatin and S-1 in people with Gastric Cancer and RCT, run by Sichuan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

The purpose of this clinical trial is to evaluate whether perioperative ivonescimab in combination with S-1 and oxaliplatin (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 Cancer, RCT
What is being tested?: Ivonescimab (20mg/kg Q3W), Oxaliplatin and S-1
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 154 participants
Where: 1 siteChina
Study dates: 1 Feb 2026to 31 Dec 2027
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 N+ M0 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

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hu Qiancheng, MD contact

+86-17780026135

hqch860109@163.com

Gou Hongfeng contact

+86-18980602292

gouhongfeng1977@wchscu.cn

China1 site

West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Li Na, +86-85422654, namgal515@163.com
Chen Shiqi, +86-85423297, 905854557@qq.com

Other trials in China

About this study

Official title: Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) Versus SOX Alone for Locally Advanced Gastric or GEJ Adenocarcinoma: A Multicenter Randomized Phase II Study

Primary Objective:

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

Study Design:

Participants will be randomly assigned to receive either ivonescimab plus SOX or SOX alone to evaluate the potential added benefit of ivonescimab in this setting.

Participation Details:

Participants will receive the assigned treatment (ivonescimab plus SOX or SOX alone) every 21 days for approximately 4 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.

Read the detailed description

To evaluate the efficacy and safety of ivonescimab in combination with S-1 and oxaliplatin (SOX) for the treatment of locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in the neoadjuvant (perioperative) setting, with the goal of improving the pathological complete response (pCR) rate.

Conditions: Gastric Cancer, RCT
Being tested: Ivonescimab (20mg/kg Q3W), Oxaliplatin, S-1
Keywords: gastric cancer, Ivonescimab, neoadjuvant treatment
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ivonescimab (20mg/kg Q3W)Drug
ivonescimab (20 mg/kg), four 3-week cycles were administered; ivonescimab was not administered in cycle 4. .
OxaliplatinDrug
Oxaliplatin (130 mg/m², administered intravenously on day 1), four 3-week cycles were administered.
S-1Drug
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.

Study groups in NCT07374250
Study group	Role	What they receive
SOX	Active comparator	oxaliplatin, S-1, four 3-week cycles were administered. Receives: Drug: Oxaliplatin; Drug: S-1
ISOX	Experimental	In the ISOX group, the regimen included ivonescimab, oxaliplatin, and S-1. Receives: Drug: Ivonescimab (20mg/kg Q3W); Drug: Oxaliplatin; Drug: S-1

What is being measured

The primary outcome is the main question the study is designed to answer.

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
major pathologic response
defined as ≤10% residual viable tumor cells in the resected primary tumor specimen after neoadjuvant therapy;
Measured: Perioperative
R0 resection
defined as microscopically margin-negative resection
Measured: Perioperative
overall survival (OS)
defined as the time from randomization to death from any cause;
Measured: Through study completion,an average of 2 years
disease-free survival (DFS)
defined as the time from the post-surgery baseline scan to the first occurrence of relapse, metastasis, or death from any cause
Measured: Through study completion,an average of 2 years
safety
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
surgery-related complications
were graded according to the Clavien-Dindo classification;
Measured: Through study completion,an average of 2 years
An exploratory endpoint
was the evaluation of potential predictive biomarkers associated with treatment response
Measured: Through study completion,an average of 2 years
Quality of life
Quality of life was assessed using the EORTC QLQ-STO22 and 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: Perioperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202631 Dec 2027

First posted28 Jan 2026
Study start1 Feb 2026 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Gastric CancerStudies 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
Model description: Ivonescimab Plus S-1 and Oxaliplatin (SOX)
Masking: None (open label)
Enrolment: 154 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07374250
Sponsor's protocol ID: Huaxi gastric cancer
Other IDs: Huaxi
Acronym: Huaxi
Status last verified: Jan 2026
First submitted: 10 Dec 2025
Last updated: 28 Jan 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.

Publications

Andre T, Tougeron D, Piessen G, de la Fouchardiere C, Louvet C, Adenis A, Jary M, Tournigand C, Aparicio T, Desrame J, Lievre A, Garcia-Larnicol ML, Pudlarz T, Cohen R, Memmi S, Vernerey D, Henriques J, Lefevre JH, Svrcek M. Neoadjuvant Nivolumab Plus Ipilimumab and Adjuvant Nivolumab in Localized Deficient Mismatch Repair/Microsatellite Instability-High Gastric or Esophagogastric Junction Adenocarcinoma: The GERCOR NEONIPIGA Phase II Study. J Clin Oncol. 2023 Jan 10;41(2):255-265. doi: 10.1200/JCO.22.00686. Epub 2022 Aug 15.
PubMed 35969830
Lorenzen S, Gotze TO, Thuss-Patience P, Biebl M, Homann N, Schenk M, Lindig U, Heuer V, Kretzschmar A, Goekkurt E, Haag GM, Riera-Knorrenschild J, Bolling C, Hofheinz RD, Zhan T, Angermeier S, Ettrich TJ, Siebenhuener AR, Elshafei M, Bechstein WO, Gaiser T, Loose M, Sookthai D, Kopp C, Pauligk C, Al-Batran SE; AIO and SAKK Study Working Groups. Perioperative Atezolizumab Plus Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel for Resectable Esophagogastric Cancer: Interim Results From the Randomized, Multicenter, Phase II/III DANTE/IKF-s633 Trial. J Clin Oncol. 2024 Feb 1;42(4):410-420. doi: 10.1200/JCO.23.00975. Epub 2023 Nov 14.
PubMed 37963317
Shah MA, Kennedy EB, Alarcon-Rozas AE, Alcindor T, Bartley AN, Malowany AB, Bhadkamkar NA, Deighton DC, Janjigian Y, Karippot A, Khan U, King DA, Klute K, Lacy J, Lee JJ, Mehta R, Mukherjee S, Nagarajan A, Park H, Saeed A, Semrad TJ, Shitara K, Smyth E, Uboha NV, Vincelli M, Wainberg Z, Rajdev L. Immunotherapy and Targeted Therapy for Advanced Gastroesophageal Cancer: ASCO Guideline. J Clin Oncol. 2023 Mar 1;41(7):1470-1491. doi: 10.1200/JCO.22.02331. Epub 2023 Jan 5.
PubMed 36603169
Chao J, Fuchs CS, Shitara K, Tabernero J, Muro K, Van Cutsem E, Bang YJ, De Vita F, Landers G, Yen CJ, Chau I, Elme A, Lee J, Ozguroglu M, Catenacci D, Yoon HH, Chen E, Adelberg D, Shih CS, Shah S, Bhagia P, Wainberg ZA. Assessment of Pembrolizumab Therapy for the Treatment of Microsatellite Instability-High Gastric or Gastroesophageal Junction Cancer Among Patients in the KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 Clinical Trials. JAMA Oncol. 2021 Jun 1;7(6):895-902. doi: 10.1001/jamaoncol.2021.0275.
PubMed 33792646
Nie RC, Chen GM, Yuan SQ, Kim JW, Zhou J, Nie M, Feng CY, Chen YB, Chen S, Zhou ZW, Wang Y, Li YF. Adjuvant Chemotherapy for Gastric Cancer Patients with Mismatch Repair Deficiency or Microsatellite Instability: Systematic Review and Meta-Analysis. Ann Surg Oncol. 2022 Apr;29(4):2324-2331. doi: 10.1245/s10434-021-11050-6. Epub 2021 Nov 18.
PubMed 34796431
Choi YY, Bae JM, An JY, Kwon IG, Cho I, Shin HB, Eiji T, Aburahmah M, Kim HI, Cheong JH, Hyung WJ, Noh SH. Is microsatellite instability a prognostic marker in gastric cancer? A systematic review with meta-analysis. J Surg Oncol. 2014 Aug;110(2):129-35. doi: 10.1002/jso.23618. Epub 2014 Apr 15.
PubMed 24737677
Pietrantonio F, Miceli R, Raimondi A, Kim YW, Kang WK, Langley RE, Choi YY, Kim KM, Nankivell MG, Morano F, Wotherspoon A, Valeri N, Kook MC, An JY, Grabsch HI, Fuca G, Noh SH, Sohn TS, Kim S, Di Bartolomeo M, Cunningham D, Lee J, Cheong JH, Smyth EC. Individual Patient Data Meta-Analysis of the Value of Microsatellite Instability As a Biomarker in Gastric Cancer. J Clin Oncol. 2019 Dec 10;37(35):3392-3400. doi: 10.1200/JCO.19.01124. Epub 2019 Sep 12.
PubMed 31513484
Tran-Minh ML, Lehmann-Che J, Lambert J, Theou-Anton N, Pote N, Dior M, Mary F, Goujon G, Gardair C, Schischmanoff O, Kaci R, Cucherousset N, Bertheau P, Couvelard A, Aparicio T; for NORDICAP. Prevalence and prognosis of microsatellite instability in oesogastric adenocarcinoma, NORDICAP 16-01. Clin Res Hepatol Gastroenterol. 2021 Jul;45(4):101691. doi: 10.1016/j.clinre.2021.101691. Epub 2021 Apr 20.
PubMed 33852952
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338
Arnold M, Ferlay J, van Berge Henegouwen MI, Soerjomataram I. Global burden of oesophageal and gastric cancer by histology and subsite in 2018. Gut. 2020 Sep;69(9):1564-1571. doi: 10.1136/gutjnl-2020-321600. Epub 2020 Jun 30.
PubMed 32606208

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) Versus SOX Alone for Locally Advanced Gastric or GEJ Adenocarcinoma: A Multicenter Randomized Phase II Study
ClinicalTrials.gov ID: NCT07374250
Acronym / sponsor ID: Huaxi / Huaxi gastric cancer
Conditions: Gastric Cancer, RCT
Keywords: gastric cancer, Ivonescimab, neoadjuvant treatment
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 154 participants (estimated)
Lead sponsor: Sichuan UniversityUniversity, hospital or other
Study start: 1 Feb 2026 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 28 Jan 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.

Primary Objective:

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

Study Design:

Participants will be randomly assigned to receive either ivonescimab plus SOX or SOX alone to evaluate the potential added benefit of ivonescimab in this setting.

Participation Details:

Participants will receive the assigned treatment (ivonescimab plus SOX or SOX alone) every 21 days for approximately 4 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Ivonescimab Plus S-1 and Oxaliplatin (SOX)

Arm	Type	Receives
SOX	Active comparator	Drug: Oxaliplatin, Drug: S-1oxaliplatin, S-1, four 3-week cycles were administered.
ISOX	Experimental	Drug: Ivonescimab (20mg/kg Q3W), Drug: Oxaliplatin, Drug: S-1In the ISOX group, the regimen included ivonescimab, oxaliplatin, and S-1.

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 N+ M0 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
Ivonescimab (20mg/kg Q3W)ivonescimab (20 mg/kg), four 3-week cycles were administered; ivonescimab was not administered in cycle 4. .	Drug	ISOX
OxaliplatinOxaliplatin (130 mg/m², administered intravenously on day 1), four 3-week cycles were administered.	Drug	ISOX, SOX
S-1S-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.	Drug	ISOX, SOX

Primary outcome

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

9 secondary outcomes

Event-free survival (EFS)
Time frame: Through study completion,an average of 2 years
major pathologic response
Time frame: Perioperative
R0 resection
Time frame: Perioperative
overall survival (OS)
Time frame: Through study completion,an average of 2 years
disease-free survival (DFS)
Time frame: Through study completion,an average of 2 years
safety
Time frame: Through study completion,an average of 2 years
surgery-related complications
Time frame: Through study completion,an average of 2 years
An exploratory endpoint
Time frame: Through study completion,an average of 2 years
Quality of life
Time frame: Perioperative

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 28 Jan 2026.
Results publication: PubMed 35969830Andre T, Tougeron D, Piessen G, de la Fouchardiere C, Louvet C, Adenis A, Jary M, Tournigand C, Aparicio T, Desrame J, Lievre A, Garcia-Larnicol ML, Pudlarz T, Cohen R, Memmi S, Vernerey D, Henriques J, Lefevre JH, Svrcek M. Neoadjuvant Nivolumab Plus Ipilimumab and Adjuvant Nivolumab in Localized Deficient Mismatch Repair/Microsatellite Instability-High Gastric or Esophagogastric Junction Adenocarcinoma: The GERCOR NEONIPIGA Phase II Study. J Clin Oncol. 2023 Jan 10;41(2):255-265. doi: 10.1200/JCO.22.00686. Epub 2022 Aug 15.
Results publication: PubMed 37963317Lorenzen S, Gotze TO, Thuss-Patience P, Biebl M, Homann N, Schenk M, Lindig U, Heuer V, Kretzschmar A, Goekkurt E, Haag GM, Riera-Knorrenschild J, Bolling C, Hofheinz RD, Zhan T, Angermeier S, Ettrich TJ, Siebenhuener AR, Elshafei M, Bechstein WO, Gaiser T, Loose M, Sookthai D, Kopp C, Pauligk C, Al-Batran SE; AIO and SAKK Study Working Groups. Perioperative Atezolizumab Plus Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel for Resectable Esophagogastric Cancer: Interim Results From the Randomized, Multicenter, Phase II/III DANTE/IKF-s633 Trial. J Clin Oncol. 2024 Feb 1;42(4):410-420. doi: 10.1200/JCO.23.00975. Epub 2023 Nov 14.
Results publication: PubMed 36603169Shah MA, Kennedy EB, Alarcon-Rozas AE, Alcindor T, Bartley AN, Malowany AB, Bhadkamkar NA, Deighton DC, Janjigian Y, Karippot A, Khan U, King DA, Klute K, Lacy J, Lee JJ, Mehta R, Mukherjee S, Nagarajan A, Park H, Saeed A, Semrad TJ, Shitara K, Smyth E, Uboha NV, Vincelli M, Wainberg Z, Rajdev L. Immunotherapy and Targeted Therapy for Advanced Gastroesophageal Cancer: ASCO Guideline. J Clin Oncol. 2023 Mar 1;41(7):1470-1491. doi: 10.1200/JCO.22.02331. Epub 2023 Jan 5.
Results publication: PubMed 33792646Chao J, Fuchs CS, Shitara K, Tabernero J, Muro K, Van Cutsem E, Bang YJ, De Vita F, Landers G, Yen CJ, Chau I, Elme A, Lee J, Ozguroglu M, Catenacci D, Yoon HH, Chen E, Adelberg D, Shih CS, Shah S, Bhagia P, Wainberg ZA. Assessment of Pembrolizumab Therapy for the Treatment of Microsatellite Instability-High Gastric or Gastroesophageal Junction Cancer Among Patients in the KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 Clinical Trials. JAMA Oncol. 2021 Jun 1;7(6):895-902. doi: 10.1001/jamaoncol.2021.0275.
Results publication: PubMed 34796431Nie RC, Chen GM, Yuan SQ, Kim JW, Zhou J, Nie M, Feng CY, Chen YB, Chen S, Zhou ZW, Wang Y, Li YF. Adjuvant Chemotherapy for Gastric Cancer Patients with Mismatch Repair Deficiency or Microsatellite Instability: Systematic Review and Meta-Analysis. Ann Surg Oncol. 2022 Apr;29(4):2324-2331. doi: 10.1245/s10434-021-11050-6. Epub 2021 Nov 18.
Results publication: PubMed 24737677Choi YY, Bae JM, An JY, Kwon IG, Cho I, Shin HB, Eiji T, Aburahmah M, Kim HI, Cheong JH, Hyung WJ, Noh SH. Is microsatellite instability a prognostic marker in gastric cancer? A systematic review with meta-analysis. J Surg Oncol. 2014 Aug;110(2):129-35. doi: 10.1002/jso.23618. Epub 2014 Apr 15.
Results publication: PubMed 31513484Pietrantonio F, Miceli R, Raimondi A, Kim YW, Kang WK, Langley RE, Choi YY, Kim KM, Nankivell MG, Morano F, Wotherspoon A, Valeri N, Kook MC, An JY, Grabsch HI, Fuca G, Noh SH, Sohn TS, Kim S, Di Bartolomeo M, Cunningham D, Lee J, Cheong JH, Smyth EC. Individual Patient Data Meta-Analysis of the Value of Microsatellite Instability As a Biomarker in Gastric Cancer. J Clin Oncol. 2019 Dec 10;37(35):3392-3400. doi: 10.1200/JCO.19.01124. Epub 2019 Sep 12.
Results publication: PubMed 33852952Tran-Minh ML, Lehmann-Che J, Lambert J, Theou-Anton N, Pote N, Dior M, Mary F, Goujon G, Gardair C, Schischmanoff O, Kaci R, Cucherousset N, Bertheau P, Couvelard A, Aparicio T; for NORDICAP. Prevalence and prognosis of microsatellite instability in oesogastric adenocarcinoma, NORDICAP 16-01. Clin Res Hepatol Gastroenterol. 2021 Jul;45(4):101691. doi: 10.1016/j.clinre.2021.101691. Epub 2021 Apr 20.
Results publication: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
Results publication: PubMed 32606208Arnold M, Ferlay J, van Berge Henegouwen MI, Soerjomataram I. Global burden of oesophageal and gastric cancer by histology and subsite in 2018. Gut. 2020 Sep;69(9):1564-1571. doi: 10.1136/gutjnl-2020-321600. Epub 2020 Jun 30.
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.

Hu Qiancheng, MD contact

+86-17780026135

hqch860109@163.com

Gou Hongfeng contact

+86-18980602292

gouhongfeng1977@wchscu.cn

Gou Hongfeng principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ivonescimab (20mg/kg Q3W), Oxaliplatin and S-1 in people with Gastric Cancer and RCT, run by Sichuan University at 1 site in China.

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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Hu Qiancheng, MD (+86-17780026135, hqch860109@163.com), 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; ypT0) assessed by investigators, defined as the complete absence of tumor cells in the primary tumor on pathological examination. (time frame: Perioperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07374250, which also lists 10 linked publications.

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 28 Jan 2026.