RC48 Plus AK104 as First-line Treatment for HER2-overexpressing Advanced Gastric Cancer (NCT06492317) | Clinical Trial Compass
Not Yet RecruitingPhase 2
RC48 Plus AK104 as First-line Treatment for HER2-overexpressing Advanced Gastric Cancer
China20 participantsStarted 2024-07-06
Plain-language summary
A single-arm, single-center phase II trial study to assess the efficacy and safety of disitamab vedotin plus cadonilimab as first-line therapy for HER2-overexpressing advanced stomach carcinoma
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age: more than 18 years, gender is not limited;
✓. Confirmed locally advanced or distant metastasis gastric or gastroesophageal junction adenocarcinoma that is inoperable by pathological examination;
✓. Confirmed HER2 2+or 3+ by immunohistochemistry (IHC);
✓. At least 1 measurable lesion as determined by RECIST 1.1;
✓. There is no prior systematic treatment, or the patient has received neoadjuvant/adjuvant chemotherapy, and the disease progresses or relapses more than 6 months after the treatment;
✓. Eastern Cooperative Oncology Group (ECOG)performance status of 0-1;
✓. Adequate organ function:
✓. Bone marrow function: Hemoglobin count (HGB)≥80g/L;
Exclusion criteria
✕. Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drugs;
✕. Uncontrollable cardiovascular and cerebrovascular events , such as:
✕. NYHA grade 2 or above heart failure;
✕. Unstable angina pectoris;
✕. Myocardial infarction occurred within 12 months;
What they're measuring
1
objective response rate (ORR)
Timeframe: 6 months after the last subject participating in
Trial details
NCT IDNCT06492317
SponsorThe First Affiliated Hospital of Zhengzhou University
. Supraventricular or ventricular arrhythmia with clinical significance needs treatment or intervention;
✕. Cerebral hemorrhage and cerebral infarction (except for lacunar cerebral infarction without symptoms and without treatment);
✕. Serious cardiovascular and cerebrovascular events occurred within 12 months; Uncontrolled hypertension, i.e. systolic blood pressure\>140 mmHg or diastolic blood pressure\>90 mmHg after treatment;