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Safety and Efficacy of Atezolizumab Combined to Preoperative Radio-chemotherapy in Localized Rectal Cancer

NCT03127007 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-01-22

No results posted yet for this study

Summary

The study has a phase Ib and a phase II part. The phase Ib part of the study aims to determine the safety and tolerance of administration at a fixed dosing of 1200 mg / 3 weeks, concomitantly to the standard preoperative radio-chemotherapy.

The phase II part of the study aims to explore efficacy of atezolizumab in combination with the standard preoperative chemo/radiotherapy in stage II and III rectal cancers.

Conditions

  • Rectal Neoplasms

Interventions

DRUG

Atezolizumab

Atezolizumab is given on day 1 of week 3, 6, 9 and 12 at 1200 mg IV.

DRUG

5-FU based radio-chemotherapy

IV protracted 5-FU given at 225mg/m2 over 24h 5 days/week for 5 weeks associated to radiotherapy.

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    collaborator OTHER

  • Grand Hôpital de Charleroi

    lead OTHER

Principal Investigators

  • Javier Carrasco, MD, PhD · GHdC

  • Marc Van den Eynde, MD, PhD · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-27
Primary Completion
2024-02-22
Completion
2024-10-15

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

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 NCT03127007 on ClinicalTrials.gov