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Window of Opportunity Study in Colorectal Cancer

NCT03984578 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-11-18

No results posted yet for this study

Summary

This is a window of opportunity translational study investigating the use of pre-operative pembrolizumab and chemotherapy or chemoradiotherapy in non-metastatic colorectal cancer.

Conditions

Interventions

DRUG

CAPEOX

Oral Capecitabine: 1000mg/m2 twice a day from Day 1 to 14 of a 3-week cycle, and IV Oxaliplatin: 130mg/m2 on Day 1

DRUG

Pembrolizumab

IV infusion of 200mg on Day 1 and Day 22

DRUG

Capecitabine/ 5-FU

Capecitabine: Oral dose of 825mg/m2/day twice a day on radiation days with concurrent radiation median 50.4 Gy/ 28 fractions; or 5-FU: 225mg/m2/day concurrent with radiation

DRUG

Pembrolizumab

IV infusion of 200mg on Day 1 of each cycle

DRUG

CAPEOX/Pembrolizumab

* Oral Capecitabine: 1000mg/m2 twice a day from Day 1 to 14 of a 3-week cycle. * IV Oxaliplatin: 130mg/m2 on Day 1 of a 3-week cycle. * Pembrolizumab: IV infusion of 200mg on Day 1 of a 3-week cycle.

DRUG

Pembrolizumab alone

IV infusion of 200mg 21 days from the last CAPEOX/Pembrolizumab combination dose.

PROCEDURE

Surgical resection

Performed after all medical intervention.

Sponsors & Collaborators

Principal Investigators

  • Iain Tan, MD · National Cancer Centre, Singapore

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-12
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT03984578 on ClinicalTrials.gov