Disitamab Vedotin Plus Trastuzumab in Patients With HER2 Positive GC/GEJ Patiens
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital
About this trial
This trial is a single center, single arm, open label clinical study aimed at evaluating the efficacy and safety of the combination therapy of Disitamab Vedotin and trastuzumab in the treatment of advanced HER-2 positive gastric/gastroesophageal junction tumors
Eligibility criteria
Qualifiers
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 90 × 109/L, or
hemoglobin ≥ 9g/dL;
ALT or AST levels without liver metastasis are less than 2.5 times the upper limit of the normal range; When liver metastasis occurs, ALT or AST is less than 5 times the upper limit of the normal range; Serum bilirubin is 1.5 times lower than the upper limit of the normal reference range;
Serum creatinine is lower than 1.5 times the upper limit of the normal reference range or creatinine clearance rate is ≥ 40ml/min; 9. Women of childbearing age and their spouses are willing to use effective contraceptive methods within the last 7 months of treatment.
Disqualifiers
Known to be allergic to the received therapeutic drugs or excipients;
Baseline LVEF<50% (measured by echocardiography or MUGA);
Previously received treatment with anti-HER2 ADC drugs;
Individuals who have undergone systemic immunotherapy, biologic therapy, or participated in any clinical drug trials within the past 2 weeks;
Trial design
Treatments tested in this trial
- Disitamab Vedotin(RC48) Plus Tratuzumab
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov