First-line Treatment with RC48 Plus Tislelizumab and S-1(RCTS) in Advanced Gastric Cancer (NCT05586061) | Clinical Trial Compass
Active — Not RecruitingPhase 2
First-line Treatment with RC48 Plus Tislelizumab and S-1(RCTS) in Advanced Gastric Cancer
China55 participantsStarted 2023-02-10
Plain-language summary
This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Disitamab Vedotin in Combination With Tirelizumab and S-1 as first-line treatment for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion 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 was detected as 2+or 3+ by immunohistochemistry（IHC） ;
✓. 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:
✓. Bone marrow function: i. Hemoglobin count (HGB)≥80g/L; ii. Neutrophil count (NE)≥1.5×109/L; iii. White blood cell count (WBC)≥3.5×109/L; iv. Platelet count (PLT)≥100×109/L；
Exclusion criteria
✕. 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, such as:
✕. NYHA grade 2 or above heart failure;
✕. Unstable angina pectoris;
What they're measuring
1
objective response rate (ORR)
Timeframe: 6 months after the last subject participating in