CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
Trastuzumab +2 moredrug
Likely dose
Trastuzumab 8 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02004769
NCT02004769Phase 2Completed
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Phase II Study of Trastuzumab in Combination With Chemotherapy (Docetaxel Plus Capecitabine) For First Line Treatment of Her2-Positive Advanced Gastric or Gastro-Esophageal Junction Cancer

Sun Yat-sen University·interventional·Posted Dec 9, 2013·Updated Nov 18, 2016

In Brief

A Phase 2 clinical trial evaluating Trastuzumab, Docetaxel, and 1 other intervention for Stomach Neoplasms and 2 related conditions. Completed, enrolled 67 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStomach Neoplasms, Neoplasms Metastasis, ERBB2 Gene Amplification
CountriesChina
CollaboratorsFudan University, 307 Hospital of PLA, Shandong Tumor Hospital, Tongji Hospital, West China Hospital, Shandong Provincial Hospital, Second Affiliated Hospital of Suzhou University, Tianjin Medical University General Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sixth Affiliated Hospital, Sun Yat-sen University, Nanfang Hospital, Southern Medical University

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 9, 2013
Enrollment StartNov 1, 2013
Primary CompletionJun 1, 2016
TodayJul 1, 2026
Enrollment to primary: 2.6 yearsPosted 12.6 years ago

Interventions

Trastuzumabdrug

Trastuzumab (Herceptin) will be administered at a loading dose of 8 mg/kg (on day 1) followed by 6mg/kg i.v. infusion every 3 weeks (q3w), until disease progress or intolerable toxicity.

Docetaxeldrug

Docetaxel 60mg/m2 (on day 1) every 3 weeks for 6 cycles.

Capecitabinedrug

Capecitabine (Xeloda) 2000mg/m2d, d1-14, every 3 weeks until disease progress or intolerable toxicity.