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

Conditions

Locally advanced high‑risk stage III rectal adenocarcinoma (non‑metastatic)

Brief summary

Clinical Complete Response (cCR) rate at week 24

Detailed description

OS defined as the time from inclusion until death from any cause. Patients who are alive at last follow-up news will be censored at this date., PFS defined as the time from inclusion until first documentation of progression or death, whichever occurs first., The percentage of patient with pCR defined as the complete absence of viable tumor cells, or the major pathologic response (MPR) defined as less than 10% of surviving tumor cells in in the surgical specimen., The incidence of adverse events (AEs) NCI-CTCAE v6.0, Scores from EORTC QLQ-C30 and EQ-5D-5L questionnaires at baseline, Week 6 and Week 24., Identification of predictive and prognostic biomarkers of treatment response (circulating and tumor-derived)., Correlation between radiological response (RECIST) and metabolic response (PET imaging)., Characterization of systemic and intratumoral immune modulation induced by KRC-01 and chemotherapy (flow cytometry, immunohistochemistry, single-cell RNAseq), Evaluation of circulating biomarkers (e.g., ctDNA, cytokines) and correlation with clinical response, Analysis of gut microbiome modifications during treatment and association with therapeutic outcomes., Longitudinal assessment of patient-reported quality of life and symptom burden throughout treatment and follow-up.

Related papers

No related papers found yet.

Interventions

DRUGKRC-01

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Clinical Complete Response (cCR) rate at week 24	—

Secondary

Measure	Time frame
OS defined as the time from inclusion until death from any cause. Patients who are alive at last follow-up news will be censored at this date., PFS defined as the time from inclusion until first documentation of progression or death, whichever occurs first., The percentage of patient with pCR defined as the complete absence of viable tumor cells, or the major pathologic response (MPR) defined as less than 10% of surviving tumor cells in in the surgical specimen., The incidence of adverse events (AEs) NCI-CTCAE v6.0, Scores from EORTC QLQ-C30 and EQ-5D-5L questionnaires at baseline, Week 6 and Week 24., Identification of predictive and prognostic biomarkers of treatment response (circulating and tumor-derived)., Correlation between radiological response (RECIST) and metabolic response (PET imaging)., Characterization of systemic and intratumoral immune modulation induced by KRC-01 and chemotherapy (flow cytometry, immunohistochemistry, single-cell RNAseq), Evaluation of circulating bio	—

Measure

Time frame

OS defined as the time from inclusion until death from any cause. Patients who are alive at last follow-up news will be censored at this date., PFS defined as the time from inclusion until first documentation of progression or death, whichever occurs first., The percentage of patient with pCR defined as the complete absence of viable tumor cells, or the major pathologic response (MPR) defined as less than 10% of surviving tumor cells in in the surgical specimen., The incidence of adverse events (AEs) NCI-CTCAE v6.0, Scores from EORTC QLQ-C30 and EQ-5D-5L questionnaires at baseline, Week 6 and Week 24., Identification of predictive and prognostic biomarkers of treatment response (circulating and tumor-derived)., Correlation between radiological response (RECIST) and metabolic response (PET imaging)., Characterization of systemic and intratumoral immune modulation induced by KRC-01 and chemotherapy (flow cytometry, immunohistochemistry, single-cell RNAseq), Evaluation of circulating bio

—

Outcome results

None listed