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KORTUC (KRC-01) Plus Radiotherapy for Organ Preservation in Rectal Cancer

NCT07622017 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-06-02

No results posted yet for this study

Summary

This phase II clinical trial is evaluating whether adding KRC-01 injections to standard chemoradiotherapy may improve treatment outcomes in patients with locally advanced rectal cancer without metastases.

KRC-01 is an investigational product designed to improve the effectiveness of radiotherapy by increasing oxygen levels inside tumors, which may help radiation work better. KRC-01 contains hydrogen peroxide and sodium hyaluronate and is injected directly into the tumor before radiotherapy sessions.

Previous clinical experience in Japan, including studies in several types of cancer, suggested that this approach may improve tumor oxygenation and enhance the effect of radiotherapy.

The main objective of the K-BOOST study is to evaluate how many patients achieve a complete clinical response after treatment with chemoradiotherapy combined with intratumoral KRC-01 injections, potentially allowing some patients to avoid surgery. Surgery may still be recommended depending on the individual response to treatment.

Approximately 24 patients will participate in this multicenter French study. The experimental treatment period lasts approximately 26 weeks, and participants will be followed for up to 2 years.

Conditions

Interventions

DRUG

KRC-01 (KORTUC)

Intratumoral injections administered before radiotherapy.

RADIATION

Radiotherapy

Standard radiotherapy administered with chemotherapy.

DRUG

Capecitabine

Standard chemotherapy regimen (capecitabine) administered with radiotherapy.

DRUG

CAPOX

Standard chemotherapy regimen (capecitabine and oxaliplatin), after chemoradiotherapy

DRUG

FOLFOX

Standard chemotherapy regimen (5-fluorouracil, leucovorin, and oxaliplatin), after chemoradiotherapy

PROCEDURE

Optionnal TME

Surgery with total mesorectal excision (TME) may be performed depending on tumor response and multidisciplinary team assessment

Sponsors & Collaborators

  • Kortuc, Inc.

    collaborator INDUSTRY

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-01-31
Completion
2030-07-31

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

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 NCT07622017 on ClinicalTrials.gov