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New treatment option for HER2-positive Gastric Cancer
Official title First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)
ClinicalTrials.gov ID: NCT06730373
What this study is testing
What is Disitamab Vedotin?
Disitamab Vedotin is an investigational medicine, given as an infusion into a vein, 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 is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Aged18-75 years, gender is not limited;
- Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
- HER2-Positive (IHC3+or IHC2+/FISH+) ;
- Has at least 1 measurable lesion as determined by RECIST 1.1;
- There is no systematic treatment in the past, or the patient has received neoadjuvant/adjuvant chemotherapy, but the disease progresses or relapses...
You likely can't join if
- Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
- Cardiovascular and cerebrovascular events that are not well controlled;
- Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for...
- Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control...
- Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune...
- Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a...
See the full eligibility criteria
- Aged18-75 years, gender is not limited;
- Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
- HER2-Positive (IHC3+or IHC2+/FISH+) ;
- Has at least 1 measurable lesion as determined by RECIST 1.1;
- There is no systematic treatment in the past, or the patient has received neoadjuvant/adjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Adequate organ function;
- The life expectancy is at least 3 months;
- Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
- Cardiovascular and cerebrovascular events that are not well controlled;
- Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2...
- Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);
- Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune...
- Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a history of active tuberculosis infection ≥ 1 year before recruitment should...
- Brain metastasis or leptomeningeal metastasis;
- Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug;
- Has a second clinically detectable primary malignant tumor at the time of recruitment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma...
- Any major surgery was performed ≤ 28 days before the first trial drug administration;
- History of allogeneic stem cell transplantation or organ transplantation;
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
- Binzhou, Shandong, China
- Dongying, Shandong, China
- Jinan, Shandong, China
- Jining, Shandong, China
- Liaocheng, Shandong, China
- Linyi, Shandong, China
- Qingdao, Shandong, China
- Taian, Shandong, China
- Tengzhou, Shandong, China
- Weifang, Shandong, China
- Yantai, Shandong, China
- Zibo, Shandong, 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 Zhengzhou, Henan, China; Binzhou, Shandong, China; Dongying, Shandong, China; Jinan, Shandong, China; Jining, Shandong, China; Liaocheng, Shandong, China and 7 more location(s). 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.