NCT06730373 First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)
| NCT ID | NCT06730373 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Qilu Hospital of Shandong University |
| Condition | HER2-positive Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-10-17 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief Summary
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.
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, interleuk
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