Trastuzumab Plus Docetaxel and Capecitabine For First Line Treatment of Her2-Positive Advanced Gastric Cancer
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
Patients with inoperable, locally advanced or recurrent and/or HER2-positive metastatic
gastric or gastro-esophageal junction cancer, with no prior treatment for metastatic disease
are to be recruited in the study. In the current study, the efficacy and safety of
Trastuzumab in combination with Capecitabine/Docetaxel will be evaluated in Chinese patients
with HER2 positive advanced or recurrent gastric cancer.60 patients could provide adequate
precision rather than controlling type I&II error. Assuming the target PFS is 6.7m, 60
patients will give 90% CI of (5.5, 8.4). Considering the 5% drop out rate, 65 patients will
be enrolled.
Phase:
Phase 2
Details
Lead Sponsor:
Sun Yat-sen University
Collaborators:
307 Hospital of PLA Fudan University Nanfang Hospital of Southern Medical University Second Affiliated Hospital of Suzhou University Second Affiliated Hospital, School of Medicine, Zhejiang University Shandong Provincial Hospital Shandong Tumor Hospital Sixth Affiliated Hospital, Sun Yat-sen University Tianjin Medical University General Hospital Tongji Hospital West China Hospital