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Treatment of Colorectal Liver Metastases With Immunotherapy and Bevacizumab

NCT03698461 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-01-31

No results posted yet for this study

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.

Conditions

  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Colonic Neoplasms
  • Rectal Neoplasms

Interventions

DRUG

Atezolizumab

* 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)

DRUG

Bevacizumab

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

DRUG

Oxaliplatin

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

DRUG

Levoleucovorin

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

DRUG

5-FU

* 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)

Sponsors & Collaborators

Principal Investigators

  • SunYoung Kim, Ph.D · Asan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2021-12-22
Completion
2023-10-24

Countries

  • South Korea

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03698461 on ClinicalTrials.gov