Authorised Therapeutic exploratory (Phase II) Locally advanced high‑risk stage III rectal adenocarcinoma (non‑metastatic)

Phase II Clinical Trial of KORTUC (KRC-01) Combined with Radiotherapy for Locally Advanced Rectal Cancer: Towards a New Organ Preservation Approach (K-BOOST)

EU CTIS ID: 2025-524378-40-00

What this study is testing

To assess the clinical complete response (cCR) rate after completion of the treatment combining radiotherapy and intratumoral KRC-01 injections in patients with locally advanced rectal cancer. (we select cCR over pCR because some patients might never be operated on in case of major responses).

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Males and females ≥ 18 years of age
10. Intention to undergo treatment including 5 Fu based chemoradiotherapy and CAPOX (6 cycles) or FOLFOX (9 cycles)
11. Life expectancy > 6 months
12. Acceptable organ functions, as evidenced by the laboratory data described in the protocol
13. Women of childbearing potential must have a negative serum β-HCG pregnancy test within 7 days prior to the administration of the first study treatment and/or urine pregnancy 12 hours prior to the administration of the first study treatment.
14. Patients who either do not consent to a tumor biopsy or do not have accessible lesions will not be eligible.

You likely can't join if

1. Patients not deemed fit for radiotherapy or preexisting condition which would deter radiotherapy, e.g., fistulas, severe ulcerative colitis (including subjects currently taking sulphasalazine), active Crohn’s disease, prior adhesions.
5. Participation in another clinical study with an investigational product during the last 3 months.
6. Prior rectal surgery.
7. Prior investigational treatment for rectal cancer.
9. High medical risk because of systemic diseases (e.g., uncontrolled infections, uncontrolled diabetes) in addition to the qualifying disease under study.
12. Peripheral sensory neuropathy grade ≥2 (for the future administration of oxaliplatin)

See the full eligibility criteria

Who can join

1. Males and females ≥ 18 years of age
10. Intention to undergo treatment including 5 Fu based chemoradiotherapy and CAPOX (6 cycles) or FOLFOX (9 cycles)
11. Life expectancy > 6 months
12. Acceptable organ functions, as evidenced by the laboratory data described in the protocol
13. Women of childbearing potential must have a negative serum β-HCG pregnancy test within 7 days prior to the administration of the first study treatment and/or urine pregnancy 12 hours prior to the administration of the first study treatment.
14. Patients who either do not consent to a tumor biopsy or do not have accessible lesions will not be eligible.
15. Patients should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.
16. Patient should be able and willing to comply with study visits and procedures as per protocol.
17. Patient must be affiliated to a social security system or beneficiary of the same.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
3. Histopathologically confirmed locally advanced rectal adenocarcinoma, stage III (high risk)
4. No evidence of metastatic disease on computed tomography (chest and abdomen), including resectable metastases. (M0, and no oligometastases)
5. At least one of the following criteria: cT4a, cT4b, presence of extramural invasion (EMVI+), cN2, involvement of the mesorectal fascia (MFI+), involvement of lateral lymph nodes (lat LN+)
6. Adenocarcinoma located with a lower border less than 15 cm from the anal margin
7. Primary resection without chemoradiotherapy is unlikely to achieve clear margins.
8. Tumor lesion must be mesurable by endoscopic visual assessment
9. Target tumor is accessible for intratumoral injections.

What rules you out

1. Patients not deemed fit for radiotherapy or preexisting condition which would deter radiotherapy, e.g., fistulas, severe ulcerative colitis (including subjects currently taking sulphasalazine), active Crohn’s disease, prior adhesions.
5. Participation in another clinical study with an investigational product during the last 3 months.
6. Prior rectal surgery.
7. Prior investigational treatment for rectal cancer.
9. High medical risk because of systemic diseases (e.g., uncontrolled infections, uncontrolled diabetes) in addition to the qualifying disease under study.
12. Peripheral sensory neuropathy grade ≥2 (for the future administration of oxaliplatin)
13. Dihydropyrimidine deshydrogenase (DPD) deficiency. DPD status must be assessed prior to inclusion, and uracilemia testing is mandatory before initiation of fluorouracil-based treatment. Patients with unknown DPD status are not eligible.
2. Patients with hypokalemia below the lower limit of normal, hypomagnesemia, hypocalcemia, or QT/QTc interval >450 msec in males or >470 msec in females at inclusion are not eligible.
8. Patients with known high microsatellite instability (MSI-H) or mismatch repair deficient (dMMR) tumors are not eligible, as these patients may benefit from standard-of-care immunotherapy.
10. Patients receiving therapeutic anticoagulation are not eligible. Prophylactic anticoagulation at low dose (e.g., thromboprophylaxis) may be allowed at the investigator’s discretion, provided that the bleeding risk is considered minimal.
11. Patients receiving concomitant treatment with brivudine or who have received brivudine within the previous 4 weeks.
14. Concomitant medications/comorbidities that may prevent the patient from receiving study treatments
15. Contraindication to fluoropyrimidines or oxaliplatin and capecitabin
16. Yellow fever vaccine and live attenuated vaccines are contraindicated due to the risk of severe vaccine-induced infection. Note: The currently authorized COVID-19 vaccines are not live vaccines and therefore can be safely administered.
17. Known history of human immunodeficiency virus (HIV) infection or seropositive results consistent with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
18. Pregnant or breastfeeding women or intending to become pregnant during the clinical investigation.
19. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
3. Any Previous radiotherapy in the pelvic region.
4. contraindications to MRI (e.g., subjects with pacemakers, claustrophobia, excessive weight, etc.).

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.