First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Dec 8, 2024

Keywords

ClinConnect Summary

This clinical trial, called RCTS2, is studying a new treatment approach for patients with advanced gastric cancer that tests positive for HER2, a protein that can promote cancer growth. The trial compares two treatment combinations: one includes a medication called Disitamab Vedotin along with Sintilimab and S-1, while the other uses Trastuzumab with chemotherapy and possibly Sintilimab. The goal is to see which combination works better for patients who have not received any treatment before or whose cancer has returned after previous treatment.

To participate in this trial, you need to be between 18 and 75 years old and have a specific type of gastric cancer that cannot be surgically removed or has spread to other parts of the body. You should have at least one measurable tumor, and your overall health should be stable enough for treatment. If you join the trial, you will receive one of the study treatments and be monitored closely for any side effects and how well the treatment is working. This trial is currently recruiting participants, and it’s a great opportunity for those looking for new treatment options for their cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged18-75 years, gender is not limited;
• • 2. Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
• • 3. HER2-Positive (IHC3+or IHC2+/FISH+) ;
• • 4. Has at least 1 measurable lesion as determined by RECIST 1.1;
• • 5. 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;
• • 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• • 7. Adequate organ function;
• • 8. The life expectancy is at least 3 months;
• Exclusion Criteria:
• • 1. Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
• • 2. Cardiovascular and cerebrovascular events that are not well controlled;
• • 3. 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 weeks.
• • 4. 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.);
• • 5. 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 diseases;
• • 6. 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 also be excluded, unless proved has been completed appropriate treatment;
• • 7. Brain metastasis or leptomeningeal metastasis;
• • 8. 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;
• • 9. 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 in situ);
• • 10. Any major surgery was performed ≤ 28 days before the first trial drug administration;
• • 11. History of allogeneic stem cell transplantation or organ transplantation;