UnknownPhase 2

Disitamab Vedotin Combined With PD-1 and Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer（RC48-C018）

40 participantsStarted 2021-12-18

Plain-language summary

This trial is a multi-center, open, single-arm, superior phase II clinical study.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Sign the informed consent form;
✓. Age 18-75 years old (including 18 years old and 75 years old);
✓. Expected survival period ≥ 12 weeks;
✓. ECOG physical fitness score 0 or 1 point;
✓. Patients with gastric cancer or gastroesophageal junction adenocarcinoma (Siewert type I-III) confirmed by histology and/or cytology, clinical stage T3-4aN+M0 (determined by the 8th edition of the AJCC staging system);
✓. Use pre-treatment endoscopic biopsy samples for HER2 detection in the local laboratory: HER2 high expression confirmed after IHC results (defined as: IHC 2+ 3+);
✓. Sufficient organ function:

Exclusion criteria

✕. Stage IV (metastatic) or unresectable gastric cancer or gastroesophageal junction adenocarcinoma (GEJ) as determined by the investigator;
✕. Past systemic treatment for gastric cancer;
✕. There is a history of malignant tumors in the 5 years before screening (except for gastric cancer), except for malignant tumors with negligible risk of metastasis or death (for example, 5-year OS rate\> 90%), such as cervical carcinoma in situ after appropriate treatment , Non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ or stage I uterine cancer;
✕. Severe cardiovascular and cerebrovascular events occurred within 12 months, including but not limited to unstable angina, myocardial infarction, cerebral hemorrhage and cerebral infarction (except for lacunar infarcts that are asymptomatic and do not require treatment);
✕. There are other lung diseases that require treatment or are serious, including but not limited to active tuberculosis, interstitial lung disease, etc.;
✕. Are suffering from an active infection that requires systemic treatment;
✕. There are active autoimmune diseases that require systemic treatment in the past 2 years (such as corticosteroids or immunosuppressive drugs, etc.), and related alternative treatments (such as thyroxine, insulin, or the physiological effects of adrenal or pituitary insufficiency) are allowed Corticosteroid replacement therapy);
✕. Major surgery other than diagnosis was received within 4 weeks before the start of study treatment, or major surgery is expected to be required during the study period

What they're measuring

pathologic Complete Response, PCR

Timeframe: 3 months-6 months

Trial details

NCT IDNCT05113459

SponsorGuoxin Li

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-18

Contact for this trial

liying zhao, PhD

13430396746 gzliguoxin@163.com

View on ClinicalTrials.gov More Gastric Cancer trials