NCT07098949尚未招募不适用
Multicenter Randomized Controlled Clinical Study on Acupuncture Combined With Adjuvant Chemotherapy for the Prevention of Recurrence and Metastasis After Gastric Cancer Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 346
- 试验地点
- 3
- 主要终点
- Disease free survival
研究概览
简要总结
This multicenter, randomized, parallel-group clinical trial aims to evaluate the efficacy of acupuncture combined with adjuvant chemotherapy in patients with gastric cancer who have undergone surgery. Participants will be randomly assigned in a 1:1 ratio to receive either acupuncture or sham acupuncture during the adjuvant chemotherapy period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with gastric cancer who have undergone R0 resection of the stomach/ distal stomach with D2 lymphadenectomy and are planned to receive postoperative adjuvant chemotherapy
- •Postoperative pathological diagnosis of gastric cancer, with pathological staging of pII/pIII (American Joint Committee on Cancer, AJCC)
- •No recurrence or metastasis confirmed by imaging examination
- •Performance Status (PS) score of 0-2
- •Age between 18 and 75 years
- •Normal bone marrow, liver, and kidney function:
- •Normal bone marrow function: Neutrophil count ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥90g/L
- •Normal kidney function: Serum creatinine ≤1.5mg/dl (133μmol/L) and/or creatinine clearance ≥60ml/min
- •Normal liver function: Total serum bilirubin level ≤1.5 times the upper limit of normal (ULN), serum aspartate aminotransferase (AST) & alanine aminotransferase (ALT) ≤2.5 times ULN
- •Signed informed consent, and the patient voluntarily accepts treatment according to this protocol
排除标准
- •Unable to complete baseline assessment
- •Individuals with a fear of acupuncture
- •Those planning to receive postoperative adjuvant radiotherapy
- •History of blood system diseases, organ transplant history, or those requiring long-term oral immunosuppressants
- •Individuals with implanted cardiac pacemakers
- •Those who have received acupuncture treatment within the past 6 weeks
- •Fever within 3 days prior to enrollment with a temperature above 38°C or clinically significant infections(Subject to enrollment once infection is managed)
- •Currently receiving or having used the investigational drug or device within 4 weeks prior to the first intervention of the study
- •Presence of other primary tumors
- •Pregnant or breastfeeding women, individuals with mental illness, intellectual or language disabilities, those lacking legal capacity, or those whose medical or ethical reasons affect the continuation of the study
研究组 & 干预措施
Acupuncture Treatment Group
Experimental
Acupuncture for three times every 3 weeks(once a week, one cycle of adjuvant chemotherapy), a total of 4 cycles of adjuvant chemotherapy.
干预措施: Acupuncture (Other)
Acupuncture Treatment Group
Experimental
Acupuncture for three times every 3 weeks(once a week, one cycle of adjuvant chemotherapy), a total of 4 cycles of adjuvant chemotherapy.
干预措施: Chemotherapy (Drug)
Sham Acupuncture Group
Sham Comparator
Sham acupuncture procedure at the same acupoints and treatment schedule as the acupuncture group, utilizing a blunt-tipped sham needle for superficial pressure.
干预措施: Sham Acupuncture (Other)
Sham Acupuncture Group
Sham Comparator
Sham acupuncture procedure at the same acupoints and treatment schedule as the acupuncture group, utilizing a blunt-tipped sham needle for superficial pressure.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Disease free survival
时间窗: From the date of surgery until the date of first documented tumor recurrence, distant metastasis, or death from any cause, whichever occurs first, assessed up to 5 years.
次要结局
- Average trajectory of FACT-Gastric TOI over time(Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis)
- Total AUC of FACT-Gastric Scoring(Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis)
- Average trajectory of Modified Edmonton Symptom Assessment Scale(Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis)
- Total AUC of FACT-Gastric TOI(Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis)
- Total AUC of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric(Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis)
- Average trajectory of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric(Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis)
- Chemotherapy completion rate(The number of patients who have received 8 Cycle chemotherapy divided by the total number of patients in each group, assessed up to 8 months.)
- Average trajectory of FACT-Gastric Scoring over time(Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis)
- Total AUC of Modified Edmonton Symptom Assessment Scale(Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis)
- Overall survival(From the date of surgery until the date of death from any cause, assessed up to 5 years.)
- Traditional Chinese Medicine Symptom Assessment(Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis)
研究者
研究点 (3)
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