Trial Radar KI | ||
|---|---|---|
Die klinische Studie NCT06596343 für Lokal fortgeschrittener kolorektaler Krebs, Postoperative Adjuvant Therapy ist noch nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Evaluating the Benefits of Personalized Traditional Chinese Medicine in Postoperative Treatment for Locally Advanced Colorectal Cancer Phase 2 80 Personalisiert
Study on the Value of Traditional Chinese Medicine Precision Treatment Based on Syndrome Differentiation in Postoperative Adjuvant Therapy for Locally Advanced Colorectal Cancer
- TCM-1
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellAdjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy Patients will sign an informed consent form after surgery but before starting chemotherapy, and those enrolled will receive a combination of chemotherapy and Traditional Chinese Medicine (TCM) supportive therapy.
1. Chemotherapy Regimen:
* Postoperative adjuvant chemotherapy: A dual-drug concurrent regimen will be used, with each cycle lasting 21 days. On day 1 of each cycle, oxaliplatin will be administered int...Mehr anzeigen | Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy 1. Chemotherapy Regimen:
* Postoperative adjuvant chemotherapy: A dual-drug concurrent regimen will be used, with each cycle lasting 21 days. On day 1 of each cycle, oxaliplatin will be administered intravenously at a dose of 130 mg/m². From day 1 to day 14 of each cycle, capecitabine will be taken orally at a dose of 1000 mg/m², twice daily. The treatment duration will follow the CSCO 2023 guidelines for colorec...Mehr anzeigen |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
The incidence of grade III/IV adverse events | According to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, adverse events (AEs) are graded on a scale from 1 to 5 based on severity:
* Grade I: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention required.
* Grade II: Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADLs).
* Grade III: Severe; medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADLs.
* Grade IV: Life-threatening consequences; urgent intervention required.
* Grade V: Death related to adverse event. | From the beginning of the first chemotherapy to three months after the end of the course of chemotherapy |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
3-year Disease-Free Survival | 3-year Disease-Free Survival (DFS) refers to the percentage of patients who remain free from any signs or symptoms of cancer recurrence or progression for three years after treatment. | 3 years post-treatment |
3-year Overall Survival | 3-year Overall Survival (OS) refers to the percentage of patients who are still alive three years after the start of treatment, regardless of whether the cancer has recurred or progressed. | 3 years post-treatment |
Completion rate of adjuvant chemotherapy | The completion rate of adjuvant chemotherapy is defined as the percentage of patients who successfully complete the full chemotherapy regimen within 6 months post-surgery, in accordance with the CSCO 2023 guidelines for colorectal cancer | From the beginning of the first chemotherapy to the end of the course of chemotherapy, up to 6 months. |
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 | The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) is a widely used tool for assessing the quality of life of cancer patients in clinical trials. Each subscale of the EORTC QLQ-C30 is scored on a range from 0 to 100. Score Interpretation: Higher Scores:
For functional scales (e.g., physical, role, emotional, cognitive, social functioning): Higher scores indicate a better quality of life. For symptom scales (e.g., fatigue, pain, nausea/vomiting): Higher scores indicate worse symptoms or problems.
The global health status/QoL scale: Higher scores indicate a better overall quality of life. | From the beginning of the first chemotherapy to three months after the end of the course of chemotherapy |
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer Module （EORTC QLQ-CR29） | The EORTC QLQ-CR29 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer Module) is a supplementary tool to the EORTC QLQ-C30, specifically designed to assess the quality of life in patients with colorectal cancer. Similar to the EORTC QLQ-C30, each item or subscale in the EORTC QLQ-CR29 is scored on a scale of 0 to 100.
Score Interpretation: Higher Scores: For functional scales (e.g., body image, sexual functioning): Higher scores reflect better functioning and, thus, a better quality of life. For symptom scales (e.g., bowel symptoms, urinary symptoms, blood/mucus in stool): Higher scores indicate worse symptoms, reflecting a worse outcome. | From the beginning of the first chemotherapy to three months after the end of the course of chemotherapy |
1. Age between 18 and 75 years. 2. Diagnosed with colorectal cancer at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, and underwent standard radical colorectal cancer surgery. Postoperative pathological staging is stage III (AJCC 8th edition: T4, any N+, M0, or any T, N2, M0), indicating the need for chemotherapy according to the CSCO 2023 colorectal cancer guidelines.
3. Willing to receive Traditional Chinese Medicine (TCM) treatment. 4. Voluntarily agree to participate in the study and sign the informed consent form. If the subject is unable to read or sign the consent due to incapacity, the informed consent must be obtained from a legal guardian. If the subject cannot read the consent (e.g., illiterate subjects), a witness must observe and sign the consent process.
5. Expected survival of ≥12 months. 6. ECOG performance status score of 0-1. 7. No prior anti-cancer, immunotherapy, or radiation treatment. 8. Laboratory tests meeting the following criteria:
White blood cell count ≥3.5 × 10^9/L, absolute neutrophil count ≥1.8 × 10^9/L, platelet count ≥100 × 10^9/L, hemoglobin ≥100 g/L.
INR ≤1.5 and APTT ≤1.5 times the upper limit of normal (ULN) or PTT ≤1.5 times ULN.
Total bilirubin ≤1.25 times ULN; ALT and AST ≤3 times ULN; serum albumin ≥28 g/L.
24-hour creatinine clearance rate ≥50 mL/min or serum creatinine ≤1.5 times ULN.
1. Colorectal cancer patients with distant metastasis as indicated by preoperative evaluation.
2. Postoperative pathological results indicate that chemotherapy is not required according to the CSCO 2023 colorectal cancer guidelines.
3. Patients who have received neoadjuvant chemoradiotherapy before surgery. 4. Patients with severe heart, liver, kidney damage, or bone marrow dysfunction.
5. Pregnant or breastfeeding women. 6. Patients with known allergies to Traditional Chinese Medicine components. 7. Patients who refuse chemotherapy or TCM treatment. 8. Patients with a history of mental illness or cognitive impairment.
Sir Run Run Shaw HospitalChina