CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
SHR-1210 +3 morebiological
Likely dose
Capecitabine 1000 mgfrom 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/NCT03472365
NCT03472365Phase 2Completed

A Randomized Phase 2 Study to Evaluate Safety and Efficacy of the Combination of SHR-1210 With Capecitabine + Oxaliplatin or Apatinib as First-line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Jiangsu HengRui Medicine Co., Ltd.·interventional·Posted Mar 21, 2018·Updated Jan 11, 2024

In Brief

A Phase 2 clinical trial evaluating SHR-1210, Capecitabine, and 2 other interventions for Gastric Cancer and GastroEsophageal Cancer. Completed, enrolled 67 participants across 1 site.

Detailed Summary

The purpose of this trial is to estimate overall response rate (ORR) of SHR-1210 combined with capecitabine and oxaliplatin or with apatinib as first-line treatment in subjects with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMar 21, 2018
Enrollment StartApr 2, 2018
Primary CompletionNov 25, 2020
TodayJul 1, 2026
Enrollment to primary: 2.6 yearsPosted 8.3 years ago

Interventions

SHR-1210biological

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

Capecitabinedrug

1000 mg/m\^2 administered as continuous oral twice daily (BID) of each 3-week cycle.

Oxaliplatindrug

130 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle.

Apatinibdrug

375 mg administered as continuous oral once daily (QD) of each 3-week cycle.