CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
Nivolumab +1 moredrug
Likely dose
Nivolumab 3 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/NCT03453164
NCT03453164Phase 2Completed

Combination of Checkpoint Inhibitor and Radiotherapy for Recurrent Gastric Cancer After Initial Treatment With Standard Therapy (CIRCUIT).

Fukushima Medical University·interventional·Posted Mar 5, 2018·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating Radiotherapy and Nivolumab for Gastric Cancer. Completed, enrolled 41 participants across 1 site.

Detailed Summary

This study aims to evaluate safety and efficacy of nivolumab (anti-PD-1 antibody), which is approved as tertiary therapy, and neoadjuvant short-term limited local radiotherapy in patients with unresectable recurrent gastric cancer who progressed (intolerance or PD) after standard treatment (primary and secondary chemotherapy) and have more than one lesion assessable in diagnostic imaging (one lesion must be \>=2cm).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMar 5, 2018
Enrollment StartMar 28, 2018
Primary CompletionJan 7, 2021
Study CompletionJan 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.3 years ago

Interventions

Radiotherapyradiation

Radiotherapy of 22.5 Gy/5 fractions/5 days was given to a symptomatic lesion or the largest asymptomatic lesion suitable for irradiation from Day 1.

Nivolumabdrug

Nivolumab was administered intravenously starting on Day 15-22 at a dose of 3 mg/kg (body weight) or 240 mg/body every 2 weeks to a total of 6 courses of administration.