First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQilu Hospital of Shandong University
About this trial
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
Qualifiers
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;
Disqualifiers
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 weeks.
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.);
Trial design
Treatments tested in this trial
- Disitamab Vedotin
- Sintilimab
- S-1
- Trastuzumab
- Oxaliplatin
- Capecitabine
- 5-FU
- Cisplatin
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov