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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression

Clinical Study on the Efficacy and Safety of Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression

Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression (NCT06560528) is a Phase 2 interventional studying Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, sponsored by Tianjin Medical University Cancer Institute and Hospital. 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 efficacy and safety of combination with Disitamab Vedotin and with Tislelizumab and Capecitabine for perioperative treatment of locally advanced gastric cancer with HER2 overexpression.

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.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 1\) Volunteer to take part in the study ; - 2\) Age 18\~75 (including 75), male or female; - 3\) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology; - 4\) Clinical stage Ⅱ, Ⅲ (cT2-4a ,N+ or -, M0, AJCC 8th); - 5\) Have not received systematic treatment; - 6\) The HER2 immunohistochemistry (IHC) test result is IHC 3+or 2+, and the previous test results of the subject (confirmed by the investigator) are acceptable; - 7\) At least one assessable lesion (RECIST 1.1 ); - 8\) Expected survival time ≥ 6 months; - 9\) ECOG 0-1; - 10\) Major organs are functioning normally; Who Should NOT Join This Trial: - 1\) Have a history of malignant tumors other than gastric cancer, except for the following two cases: 1. The patient has received possible curative treatment and there is no evidence of the disease within 5 years; 2. The resected skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ and other carcinoma in situ were successfully received; - 2\) Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc.); - 3\) Have received allogeneic stem cells or solid organ transplantation in the past; - 4\) Patients who have received other anti-tumor systemic therapy in the past (including traditional Chinese medicine with anti-tumor indications), and have been less than 4 weeks from the completion of treatment to the administration of this study, or the adverse events caused by previous treatment have not recovered to ≤ CTCAE level 1 (except hair loss and pigmentation); - 5\) Previous or current congenital or acquired weakened immune system disease; ...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\) Volunteer to take part in the study ; * 2\) Age 18\~75 (including 75), male or female; * 3\) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology; * 4\) Clinical stage Ⅱ, Ⅲ (cT2-4a ,N+ or -, M0, AJCC 8th); * 5\) Have not received systematic treatment; * 6\) The HER2 immunohistochemistry (IHC) test result is IHC 3+or 2+, and the previous test results of the subject (confirmed by the investigator) are acceptable; * 7\) At least one assessable lesion (RECIST 1.1 ); * 8\) Expected survival time ≥ 6 months; * 9\) ECOG 0-1; * 10\) Major organs are functioning normally; Exclusion Criteria: * 1\) Have a history of malignant tumors other than gastric cancer, except for the following two cases: 1. The patient has received possible curative treatment and there is no evidence of the disease within 5 years; 2. The resected skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ and other carcinoma in situ were successfully received; * 2\) Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc.); * 3\) Have received allogeneic stem cells or solid organ transplantation in the past; * 4\) Patients who have received other anti-tumor systemic therapy in the past (including traditional Chinese medicine with anti-tumor indications), and have been less than 4 weeks from the completion of treatment to the administration of this study, or the adverse events caused by previous treatment have not recovered to ≤ CTCAE level 1 (except hair loss and pigmentation); * 5\) Previous or current congenital or acquired immunodeficiency disease; * 6\) Active or previously recorded autoimmune diseases or inflammatory diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, hypophysitis, hyperthyroidism or hypothyroidism, asthma requiring bronchodilators, etc.), vitiligo or asthma that has completely alleviated in childhood, Those who do not need any intervention after adulthood can be included; * 7\) Systemic immunosuppressive drugs were used within 2 weeks before enrollment, or were expected to be required during the study, except for the following: 1. Corticosteroids for intranasal, inhalation, external or local injection (such as intra-articular injection); 2. The dose of prednisone or other equivalent systemic corticosteroids does not exceed 10 mg/day; 3. Preventive use of corticosteroids for hypersensitivity; * 8\) Allergic to the study drug; * 9\) Thrombosis or thromboembolism events occurred in the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc; * 10\) Patients at risk for severe bleeding; * 11\) Cardiovascular diseases with significant clinical significance; * 12\) Other significant clinical and laboratory abnormalities, which the researchers think affect the safety evaluation; * 13\) Serious infection in active period or poorly controlled clinically; * 14\) Not recovered from the operation; * 15\) Pregnant or lactating women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures; * 16\) Other situations that the investigator thinks are not suitable for inclusion.

Treatments Being Tested

DRUG

combination with Disitamab Vedotin and with Tislelizumab and Capecitabine

Subjects will receive Disitamab Vedotin combined with Tislelizumab and Capecitabine for 3 cycles (Q3W) in the neoadjuvant phase and 5 cycles (Q3W) of treatment in the adjuvant phase. 1. Disitamab Vedotin:2.5 mg/kg,Q3W; 2. Tislelizumab:200 mg,Q3W; 3. Capecitabine:1000 mg /m2, PO, bid d1-14, Q3W.

Locations (2)

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.

Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Xuewei Ding
Tianjin, Tianjin Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06560528), the sponsor (Tianjin Medical University Cancer Institute and Hospital), 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 NCT06560528 clinical trial studying?

The efficacy and safety of combination with Disitamab Vedotin and with Tislelizumab and Capecitabine for perioperative treatment of locally advanced gastric cancer with HER2 overexpression. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06560528?

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 NCT06560528?

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 NCT06560528. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06560528. 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 2026-06-26 · Data from ClinicalTrials.gov.