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New treatment option for HER2-positive Gastric Cancer
Official title Disitamab Vedotin Plus Trastuzumab in Patients With HER2 Positive GC/GEJ Patiens
ClinicalTrials.gov ID: NCT06572319
What this study is testing
What is Disitamab Vedotin(RC48) Plus Tratuzumab?
Disitamab Vedotin(RC48) Plus Tratuzumab is an investigational medicine, being studied as a potential treatment for her2-positive gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial is a single center, single arm, open label clinical study aimed at evaluating the efficacy and safety of the combination therapy of Disitamab Vedotin and trastuzumab in the treatment of advanced HER-2 positive gastric/gastroesophageal junction tumors
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1\. Sign the informed consent form; 2.18-75 years old (including 18 years old, excluding 75 years old), gender not limited; 3. The pathological...
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 90 × 109/L, or
- hemoglobin ≥ 9g/dL;
- ALT or AST levels without liver metastasis are less than 2.5 times the upper limit of the normal range; When liver metastasis occurs, ALT or AST is...
- Serum creatinine is lower than 1.5 times the upper limit of the normal reference range or creatinine clearance rate is ≥ 40ml/min; 9. Women of...
You likely can't join if
- Known to be allergic to the received therapeutic drugs or excipients;
- Baseline LVEF\<50% (measured by echocardiography or MUGA);
- Previously received treatment with anti-HER2 ADC drugs;
- Individuals who have undergone systemic immunotherapy, biologic therapy, or participated in any clinical drug trials within the past 2 weeks;
- Those who have undergone surgery within 3 weeks before the start of the experimental treatment and have not fully recovered;
- Patients with uncontrolled central nervous system (CNS) metastases or epilepsy requiring medication treatment;
See the full eligibility criteria
- 1\. Sign the informed consent form; 2.18-75 years old (including 18 years old, excluding 75 years old), gender not limited; 3. The pathological histology confirmed by pathology is adenocarcinoma of the...
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 90 × 109/L, or
- hemoglobin ≥ 9g/dL;
- ALT or AST levels without liver metastasis are less than 2.5 times the upper limit of the normal range; When liver metastasis occurs, ALT or AST is less than 5 times the upper limit of the normal range; Serum bilirubin...
- Serum creatinine is lower than 1.5 times the upper limit of the normal reference range or creatinine clearance rate is ≥ 40ml/min; 9. Women of childbearing age and their spouses are willing to use effective...
- Known to be allergic to the received therapeutic drugs or excipients;
- Baseline LVEF\<50% (measured by echocardiography or MUGA);
- Previously received treatment with anti-HER2 ADC drugs;
- Individuals who have undergone systemic immunotherapy, biologic therapy, or participated in any clinical drug trials within the past 2 weeks;
- Those who have undergone surgery within 3 weeks before the start of the experimental treatment and have not fully recovered;
- Patients with uncontrolled central nervous system (CNS) metastases or epilepsy requiring medication treatment;
- Serious systemic diseases. Such as infected or uncontrolled diabetes;
- Suffering from other malignant tumors within 5 years, except for non melanoma skin cancer and cervical carcinoma in situ;
- Clinically symptomatic active coronary heart disease, cardiomyopathy, or congestive heart failure, NYHA III-IV; uncontrolled hypertension (systolic blood pressure\>180 mmHg or diastolic blood pressure\>100 mmHg)...
- Patients receiving long-term or high-dose corticosteroid treatment (inhaled steroids or short-term oral steroids are allowed to resist vomiting or promote appetite)
- Individuals without legal capacity, those whose medical or ethical reasons affect the continuation of research;
- Pregnant and lactating female patients, or those who wish to become pregnant during treatment;
- Uncontrolled pleural and peritoneal effusion;
- There is a persistent infection of\>level 2 (CTC-AE 4.0); Wounds, ulcers, or fractures that cannot heal, or patients with a history of organ transplantation;
- There are unresolved toxicity levels\>1 caused by any previous treatment/procedure (CTC-AE 4.0, excluding hair loss, anemia, and hypothyroidism);
- After comprehensive assessment of the patient's condition by the researchers, it is deemed that they are not suitable to participate in this study;
- Simultaneously participating in another clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.