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

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT07622017
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KRC-01 (KORTUC) — DRUG
    Intratumoral injections administered before radiotherapy.
  • Radiotherapy — RADIATION
    Standard radiotherapy administered with chemotherapy.
  • Capecitabine — DRUG
    Standard chemotherapy regimen (capecitabine) administered with radiotherapy.
  • CAPOX — DRUG
    Standard chemotherapy regimen (capecitabine and oxaliplatin), after chemoradiotherapy
  • FOLFOX — DRUG
    Standard chemotherapy regimen (5-fluorouracil, leucovorin, and oxaliplatin), after chemoradiotherapy
  • Optionnal TME — PROCEDURE
    Surgery with total mesorectal excision (TME) may be performed depending on tumor response and multidisciplinary team assessment

Study Details

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.

Key Dates

First listed
Jun 2, 2026
Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Jan 31, 2029
Completion
Jul 31, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intratumoral KRC-01 injections combined with standard chemoradiotherapy
    Participants receive intratumoral KRC-01 injections (8 injections) combined with standard long-course chemoradiotherapy (radiotherapy: 50 Gy in 25 fractions plus capecitabine 825 mg/m² orally twice daily for 5 weeks) and consolidation chemotherapy with CAPOX or FOLFOX according to investigator decision and institutional practice. Surgery with total mesorectal excision (TME) may be performed depending on tumor response and multidisciplinary team assessment.

Primary Outcome Measure

Clinical Complete Response (cCR) Rate at Week 24 [ Time Frame: Week 24 ]

Central Contacts

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