CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Atezolizumab +4 moredrug
Likely dose
Atezolizumab 1200mgfrom 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/NCT03698461
NCT03698461Phase 2Completed

Comparative Analysis of Immune Profile Following Neoadjuvant Chemotherapy in Colorectal Liver Metastases (CRLM): A Prospective Pilot Clinical Trial

Asan Medical Center·interventional·Posted Oct 9, 2018·Updated Jan 31, 2024

In Brief

A Phase 2 clinical trial evaluating Atezolizumab, Bevacizumab, and 3 other interventions for Colorectal Neoplasms and 3 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Liver is the most common site of metastases from colorectal cancer. Neoadjuvant chemotherapy with targeted agents is usually recommended for borderline-resectable liver metastases that are technically difficult to resect for conversion to resectable disease and control of metastatic spread. However, the prognosis of these patients are still poor, and long term disease-free survival over 3 years is rare and \<20%. More effective measures to prevent recurrence are needed before or after resection of colorectal liver metastases.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
CollaboratorsHoffmann-La Roche

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 9, 2018
Enrollment StartMay 15, 2019
Primary CompletionDec 22, 2021
Study CompletionOct 24, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.7 years ago

Interventions

Atezolizumabdrug

* 1200mg IV on day1 before start of cycle 'atezolizuamb, bevacizumab + FOLFOX(Oxaliplatin, Levoleucovorin, 5-FU') * 840mg IV D1 of C1-12 (Cycle: every 2 weeks)

Bevacizumabdrug

5mg/kg IV D1 of C1-12 (Cycle: every 2 weeks) at least 5 minutes after completion of atezolizumab

Oxaliplatindrug

85mg/m2 IV D1 of C1-12 (Cycle: every 2 weeks)

Levoleucovorindrug

200mg/m2 IV D1 of C1-12 (Cycle: every 2 weeks)

5-FUdrug

* 5-FU Bolus: 400mg/m2 IV bolus D1 of C1-12 (Cycle: every 2 weeks) * 5-FU infusion: 2400mg/mg continuous IV infusion over 46hours D1-3 of C1-12 (Cycle: every 2 weeks)