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OncoMatch/Clinical Trials/NCT06730373

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

Is NCT06730373 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for her2-positive gastric cancer.

Phase 2RecruitingQilu Hospital of Shandong UniversityNCT06730373Data as of May 2026

Treatment: Disitamab Vedotin · Sintilimab · S-1 · Trastuzumab · Oxaliplatin · Capecitabine · 5-FU · Cisplatin — 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.

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Extracted eligibility criteria

Cancer type

Gastric Cancer

Biomarker criteria

Required: HER2 (ERBB2) overexpression (IHC3+ or IHC2+/FISH+)

HER2-Positive (IHC3+or IHC2+/FISH+)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 0 prior lines

Cannot have received: systemic therapy

Exception: neoadjuvant/adjuvant chemotherapy allowed if relapse >6 months after end of treatment

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

Cannot have received: systemic Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) (thymosin, interferon, interleukin)

Exception: local use for ascites control

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

Lab requirements

Blood counts

Kidney function

Liver function

Adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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