治験レーダーAI | ||
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治験 NCT07413146（対象：最小残存病変、Immunoscore、術前補助化学療法、Colon Cancer (Stage II &Amp; III)）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
中山大学Neoadjuvant CAPEOX Versus Upfront Surgery for Locally Advanced Colon Cancer With Elevated CEA: A Single-Center, Open-Label, Randomized Controlled Trial 100 費用負担なし バイオマーカー 無作為化 非盲検
Neoadjuvant CAPEOX Versus Upfront Surgery for Locally Advanced Colon Cancer With Elevated CEA: A Single-Center, Open-Label, Randomized Controlled Trial
- 2025-FXY-317
Minimal Residual Disease
Immunoscore
neoadjuvant chemotherapy
upfront surgery
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Neoadjuvant Chemotherapy before R0-planned Surgery ± adjuvant chemotherapy Participants in this arm receive 4 cycles of standard neoadjuvant CAPOX (CAPEOX) prior to curative-intent surgery. Postoperative adjuvant chemotherapy is determined based on the postoperative pathologic stage and risk stratification (per current CSCO guideline criteria). High-risk stage III participants receive an additional 4 cycles of CAPOX. For low-risk stage III or stage II participants, either no additional adju...もっと見る | ctDNA-Based Molecular Residual Disease (MRD) Monitoring and Immunoscore Assessment This study uses personalized circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) monitoring together with tumor immune profiling (Immunoscore) for postoperative risk stratification. At baseline, primary tumor tissue obtained by endoscopy and/or surgery undergoes next-generation sequencing/whole-exome sequencing to identify patient-specific somatic variants and to build an individualized ctDNA MRD ass...もっと見る 新補助化学療法 In ARM A, patient receive neoadjuvant CAPEOX chemotherapy for 4 cycles before surgery. 補助化学療法 The application of post-operative adjuvant chemotherapy depends on the final pathological staging, under the guidance of the NCCN/ESMO/CSCO guidelines for colorectal cancer. |
実薬対照薬Upfront R0-planned Surgery followed by adjuvant chemotherapy In this arm, participants undergo upfront curative-intent (radical) surgery after standard preoperative assessment and staging. Postoperative adjuvant chemotherapy is administered per current CSCO guidelines based on pathologic stage and risk factors, with regimen selection determined by the treating physician in discussion with the patient. | ctDNA-Based Molecular Residual Disease (MRD) Monitoring and Immunoscore Assessment This study uses personalized circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) monitoring together with tumor immune profiling (Immunoscore) for postoperative risk stratification. At baseline, primary tumor tissue obtained by endoscopy and/or surgery undergoes next-generation sequencing/whole-exome sequencing to identify patient-specific somatic variants and to build an individualized ctDNA MRD ass...もっと見る 補助化学療法 The application of post-operative adjuvant chemotherapy depends on the final pathological staging, under the guidance of the NCCN/ESMO/CSCO guidelines for colorectal cancer. |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
2-year Disease-Free Survival (2y-DFS) | Disease-free survival is defined as the time from curative-intent surgery to the first occurrence of any of the following events: (1) local recurrence, (2) distant metastasis, (3) a second primary colorectal cancer, or (4) death from any cause, whichever occurs first. Participants without an event will be censored at the last disease assessment. | From date of surgery up to 24 months postoperatively. |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
2-year Overall Survival (2y-OS) | Overall survival is defined as the time from curative-intent surgery to death from any cause. Participants alive at the end of follow-up will be censored at the last known date alive. | From date of surgery up to 24 months postoperatively. |
Local Recurrence Rate at 2 years | Proportion of participants who develop local recurrence (tumor recurrence at or adjacent to the primary tumor bed/anastomosis and/or regional sites consistent with local-regional relapse, as determined by standard clinical assessment and imaging/pathology when available) within 24 months after surgery. | Up to 24 months postoperatively. |
Participants must meet all of the following criteria:
Age 18 to 70 years (inclusive) at the time of written informed consent. ECOG performance status 0-1, without deterioration within 2 weeks prior to enrollment; anticipated life expectancy ≥12 weeks.
Histologically or cytologically confirmed colon adenocarcinoma, non-MSI-H/dMMR, with pathologic stage (AJCC/UICC TNM 8th edition) of:
High-risk stage II, or Stage III. High-risk stage II features include: T4, poor/undifferentiated histology (high grade; excluding MSI-H), lymphovascular invasion, perineural invasion, preoperative bowel obstruction or tumor perforation, positive/unknown margin status, insufficient margin clearance, <12 lymph nodes examined, or high-grade tumor budding.
Tumor location consistent with colon cancer: distal tumor margin ≥12 cm from the anal verge on preoperative endoscopy.
Baseline serum CEA >5 ng/mL prior to treatment. No evidence of distant metastasis (distant organ and/or distant lymph node metastasis) based on comprehensive clinical evaluation.
Ability to provide required clinical data for study collection. Ability to provide adequate fresh tumor tissue from endoscopy and/or surgery for WES/NGS to develop an individualized ctDNA MRD panel, and ability to provide required blood samples for ctDNA testing (baseline, postoperative ~day 7, postoperative ~day 30).
Candidate for curative-intent R0 resection. Willing and able to comply with the protocol schedule, including regular follow-up visits and necessary treatments, and provides written informed consent.
Prior or concurrent other malignant tumor. Any severe comorbidity that, in the investigator's judgment, may significantly affect follow-up or short-term survival.
Any other medical condition, or social/psychological circumstance, that in the investigator's judgment makes the participant unsuitable for the study.
MSI-H/dMMR tumor. Evidence of metastatic disease by pathology, clinical assessment, or imaging, including isolated distant lesions, distant disease, or non-contiguous intraperitoneal metastasis.
Multiple primary colon cancers. Underwent open surgery at a non-colon site within 14 days prior to enrollment. Unable to provide required tumor tissue for WES/NGS or personalized MRD panel development, personalized MRD panel customization failure, or unable to provide required blood samples (baseline, postoperative ~day 7, postoperative ~day 30).
History of blood transfusion within 2 weeks prior to surgery or intraoperatively.
Unable to undergo contrast-enhanced CT or MRI for routine clinical follow-up. Fever ≥38°C within the past 7 days, or clinically significant active infection (including active tuberculosis), or active fungal/bacterial/viral infection requiring systemic therapy.
Inadequate bone marrow reserve or organ function meeting any of the following laboratory abnormalities (within 1 week prior to testing without corrective treatment):
ANC < 1.5 × 10⁹/L Platelets < 90 × 10⁹/L Hemoglobin < 90 g/L (<9 g/dL) ALT > 3 × ULN AST > 3 × ULN or total bilirubin > 1.5 × ULN Creatinine > 1.5 × ULN or creatinine clearance < 45 mL/min (Cockcroft-Gault) Albumin < 28 g/L Pregnant or breastfeeding, or planning pregnancy during the study period. Any other condition that, in the investigator's judgment, indicates the participant should not participate.
中山大学