2025-524378-40-00招募中2 期
Phase II Clinical Trial of KORTUC (KRC-01) Combined with Radiotherapy for Locally Advanced Rectal Cancer: Towards a New Organ Preservation Approach (K-BOOST)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Clinical Complete Response (cCR) rate at week 24
研究概览
简要总结
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).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥ 18 years of age
- •Intention to undergo treatment including 5 Fu based chemoradiotherapy and CAPOX (6 cycles) or FOLFOX (9 cycles)
- •Life expectancy > 6 months
- •Acceptable organ functions, as evidenced by the laboratory data described in the protocol
- •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.
- •Patients who either do not consent to a tumor biopsy or do not have accessible lesions will not be eligible.
- •Patients should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.
- •Patient should be able and willing to comply with study visits and procedures as per protocol.
- •Patient must be affiliated to a social security system or beneficiary of the same.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Histopathologically confirmed locally advanced rectal adenocarcinoma, stage III (high risk)
- •No evidence of metastatic disease on computed tomography (chest and abdomen), including resectable metastases. (M0, and no oligometastases)
- •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+)
- •Adenocarcinoma located with a lower border less than 15 cm from the anal margin
- •Primary resection without chemoradiotherapy is unlikely to achieve clear margins.
- •Tumor lesion must be mesurable by endoscopic visual assessment
- •Target tumor is accessible for intratumoral injections.
排除标准
- •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.
- •Participation in another clinical study with an investigational product during the last 3 months.
- •Prior rectal surgery.
- •Prior investigational treatment for rectal cancer.
- •High medical risk because of systemic diseases (e.g., uncontrolled infections, uncontrolled diabetes) in addition to the qualifying disease under study.
- •Peripheral sensory neuropathy grade ≥2 (for the future administration of oxaliplatin)
- •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.
- •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.
- •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.
- •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.
- •Patients receiving concomitant treatment with brivudine or who have received brivudine within the previous 4 weeks.
- •Concomitant medications/comorbidities that may prevent the patient from receiving study treatments
- •Contraindication to fluoropyrimidines or oxaliplatin and capecitabin
- •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.
- •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.
- •Pregnant or breastfeeding women or intending to become pregnant during the clinical investigation.
- •Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
- •Any Previous radiotherapy in the pelvic region.
- •contraindications to MRI (e.g., subjects with pacemakers, claustrophobia, excessive weight, etc.).
研究组 & 干预措施
KRC-01
Test
干预措施: KRC-01 (Drug)
结局指标
主要结局
Clinical Complete Response (cCR) rate at week 24
Clinical Complete Response (cCR) rate at week 24
次要结局
- 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.
研究者
Bureau projet Promotion- DRC -Regulatory Affairs Officer
Scientific
Institut Gustave Roussy
研究点 (2)
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