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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.

A Phase II Study of Perioperative Disitamab Vedotin Plus Toripalimab and XELOX Versus Disitamab Vedotin Plus Toripalimab Versus XELOX in Subjects With HER2-expressing Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.

Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma. (NCT06155383) is a Phase 2 interventional studying Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, sponsored by RemeGen Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to evaluate the efficacy and safety of perioperative Disitamab Vedotin plus Toripalimab and XELOX versus Disitamab Vedotin plus Toripalimab versus XELOX in subjects with HER2-expressing resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Gastric Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 90 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Gastric Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Voluntarily participate and sign the willing to sign a consent form form; 2. Male or female, ≥18 years; 3. Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology; 4. Clinical stage cT3-4aN+, no distant metastasis (M0); 5. According to the baseline imaging and medical history data evaluated by the Investigators, radical surgery for gastric cancer and R0 resection is expected; Subjects had not previously received any antitumor therapy for gastric or gastroesophageal junction adenocarcinoma; 6. HER2- expression: IHC 1+, 2+, 3+; 7. ECOG performance status score of 0 or 1; 8. Cardiac function: left ventricular ejection fraction ≥50%; 9. The following criteria should be met within 7 days prior to study dosing (normal values are based on the clinical trial center): 9.1Bone marrow function: 1. absolute neutrophil count (ANC) ≥1.5×109/L (no treatment with granulocyte colony-stimulating factor within 1 week prior to examination); 2. platelet count at least 100×109/L (platelets should not be transfused within 1 week before the examination, and recombinant human thrombopoietin therapy should not be used within 2 weeks) 3. blood count (hemoglobin) at least 9g/dL (blood transfusion and erythropoietin treatment are not allowed within 2 weeks prior to the examination); 9.2Liver function: 1. Serum total bilirubin ≤1.5 times the upper limit of normal (ULN); 2. alanine amino transferase (ALT) and aspartate amino transferase (AST) ≤2.5 × ULN; 9.3 Kidney function: a.Blood creatinine ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL/min according to Cockcroft-Gault formula method; Female: CrCl= (140-age) × weight (kg) × 0.85 72 × serum creatinine (mg/dL) Male: CrCl= (140-age) × weight (kg) × 1.00 72 × serum creatinine (mg/dL) 9.4 Coagulation function: 1. prothrombin time (PT) ≤1.5×ULN; 2. thrombin time (TT) ≤ 1.5×ULN; 3. activated partial thromboplastin time (APTT) ≤ 1.5×ULN. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Voluntarily participate and sign the informed consent form; 2. Male or female, ≥18 years; 3. Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology; 4. Clinical stage cT3-4aN+, no distant metastasis (M0); 5. According to the baseline imaging and medical history data evaluated by the Investigators, radical surgery for gastric cancer and R0 resection is expected; Subjects had not previously received any antitumor therapy for gastric or gastroesophageal junction adenocarcinoma; 6. HER2- expression: IHC 1+, 2+, 3+; 7. ECOG performance status score of 0 or 1; 8. Cardiac function: left ventricular ejection fraction ≥50%; 9. The following criteria should be met within 7 days prior to study dosing (normal values are based on the clinical trial center): 9.1Bone marrow function: 1. absolute neutrophil count (ANC) ≥1.5×109/L (no treatment with granulocyte colony-stimulating factor within 1 week prior to examination); 2. Platelets ≥100×109/L (platelets should not be transfused within 1 week before the examination, and recombinant human thrombopoietin therapy should not be used within 2 weeks) 3. hemoglobin ≥9g/dL (blood transfusion and erythropoietin treatment are not allowed within 2 weeks prior to the examination); 9.2Liver function: 1. Serum total bilirubin ≤1.5 times the upper limit of normal (ULN); 2. alanine amino transferase (ALT) and aspartate amino transferase (AST) ≤2.5 × ULN; 9.3 Kidney function: a.Blood creatinine ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL/min according to Cockcroft-Gault formula method; Female: CrCl= (140-age) × weight (kg) × 0.85 72 × serum creatinine (mg/dL) Male: CrCl= (140-age) × weight (kg) × 1.00 72 × serum creatinine (mg/dL) 9.4 Coagulation function: 1. prothrombin time (PT) ≤1.5×ULN; 2. thrombin time (TT) ≤ 1.5×ULN; 3. activated partial thromboplastin time (APTT) ≤ 1.5×ULN. 10. Female subjects should be surgically sterilized, postmenopausal, or agree to use at least one medically acceptable method of contraception (e.g., intrauterine device, contraceptives, or condoms) for 7 days before the first dose and for 6 months after the end of the study treatment period, and not breastfeed. Blood pregnancy tests must be negative within 7 days prior to study enrollment. Male subjects should agree to use at least one medically approved contraceptive method (e.g., condoms, abstinence, etc.) for 7 days prior to initial dosing and up to 6 months after the end of the study treatment period; 11. Able to understand trial requirements, willing and able to follow trial and follow-up procedures. Exclusion Criteria: 1. Received any anti-tumor therapy for gastric or gastroesophageal junction adenocarcinoma before study dosing, including chemotherapy, radiotherapy, targeted therapy, immunotherapy and other anti-tumor drug therapy (including Chinese medicine treatment with anti-tumor ingredients specified in the instructions within 2 weeks before screening); 2. The investigators considered perioperative period treatment of patients requiring radiotherapy for target lesions; 3. Major surgery was performed within 4 weeks before the start of study dosing and did not fully recover; 4. Patients with active gastrointestinal bleeding or high risk of bleeding within 2 weeks prior to screening; 5. Gastrointestinal perforation/fistula 6 months before screening; 6. Upper digestive tract obstruction that cannot guarantee drug absorption, functional abnormalities or malabsorption syndrome, which can affect the absorption of capecitabine ; 7. Peripheral polyneuropathy ≥ NCI Ⅱ grade; 8. Serum virology examination (based on the normal value of the research center): * Positive HBsAg test with positive HBV DNA copy number; * Positive HCVAb test with positive HCV RNA PCR test. * Positive HIVAb test. 9. Have received live vaccine within 4 weeks prior to screening or plan to receive any vaccine during the study period (except for the novel coronavirus vaccine); 10. Heart failure rated 3 or higher by the New York College of Cardiology (NYHA); 11. Cardiac chest pain, defined as moderate pain that restricts daily activities, occurred within 28 days prior to screening. There were serious arteriovenous thrombosis events or cardiovascular and cerebrovascular accidents within six months before dosing, such as deep vein thrombosis (except asymptomatic and untreated intermuscular venous thrombosis), pulmonary embolism, cerebral infarction, cerebral hemorrhage, and myocardial infarction (except asymptomatic lacunar infarction that did not require clinical intervention); 12. There is an active or advanced infection that requires systematic treatment (experimental medication may be initiated 2 weeks after the end of anti-infective therapy), such as active tuberculosis; 13. There are systemic diseases that have not been stably controlled which are determined by investigators, including diabetes, hypertension, cirrhosis, etc.; 14. A history of lung disease that requires treatment and has the potential to interfere with surgery, including but not limited to interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, and acute lung disease; 15. Active autoimmune diseases requiring systemic therapy (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressive drugs) within 2 years prior to dose administration, and replacement therapies (e.g., thyroxine, insulin, or physiological replacement of glucocorticoids due to renal or pituitary deficiency) are allowed, and a history of refractory autoimmune disease. Systemic use of steroids within 14 days prior to screening (dose \> 10 mg/day prednisone or equivalent dose of other glucocorticoids) or other systemic immunosuppressive therapy; 16. Other malignancies within 5 years prior to screening, other than those that have been cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery); 17. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 18. Allergies to any of the drugs in this study; 19. Known deficiency of dipyrimidine dehydrogenase (DPD); 20. Receiving immunotherapy (including but not limited to interleukin, interferon, thymus hormone) or other investigational drugs within 28 days prior to screening; 21. Pregnant or lactating women; 22. Any other disease, metabolic disorder, or abnormal findings upon physical examination or laboratory examination that makes the subject unsuitable for receiving the investigational drug, affects the interpretation of study outcomes, or poses risks to patient safety, as determined by the investigator; 23. Subject is assessed to be unable or unwilling to comply with the requirements of the protocol.

Treatments Being Tested

DRUG

Capecitabine

1000 mg/m2, Bid orally, D1-14, every 3 weeks

DRUG

oxaliplatin

130 mg/m2, intravenous infusion, D1, every 3 weeks

DRUG

Disitamab Vedotin

2.5 mg/kg, intravenous infusion, D1, every 2 weeks

DRUG

Toripalimab

3.0 mg/kg, intravenous infusion, D1, every 2 weeks

Locations (11)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Yunnan Cancer Hospital
Kunming, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Shandong Cancer Hospital & Institute
Jinan, Shangdong, China
Sichuan Cancer Hospital & Institute
Chengdu, Sichuan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06155383), the sponsor (RemeGen Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06155383 clinical trial studying?

The purpose of this study is to evaluate the efficacy and safety of perioperative Disitamab Vedotin plus Toripalimab and XELOX versus Disitamab Vedotin plus Toripalimab versus XELOX in subjects with HER2-expressing resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06155383?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06155383?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06155383. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06155383. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.