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
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;
Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drugs;
NYHA grade 2 or above heart failure;
Unstable angina pectoris;
Myocardial infarction occurred within 12 months;
Single group
Disitamab Vedotin
DrugDisitamab Vedotin: 2.5mg/kg, d1, ivdrip, Q2W (every 2 weeks)
Cadonilimab
DrugCadonilimab: 6mg/kg, d1, ivdrip, Q2W (every 2 weeks)
objective response rate (ORR)
The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
duration of response (DOR)
DOR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
disease control rate (DCR)
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD) in total subjects
time to response (TTR)
TTR (per RECIST 1.1) is defined as the time from the starting date of study drug to the first time complete response (CR) or partial response (PR)
progression-free survival (PFS)
Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
