Guangzhou University of Traditional Chinese Medicine
Phase
Not applicable
Started
2025-08
Last updated
2025-08-01
Condition(s) studied
Gastric Cancer
Investigational drug(s) / intervention(s)
AcupunctureSham AcupunctureChemotherapy
Acupuncture: The patient takes a sitting or lateral position. The following acupoints are selected Baihui (GV20), Yintang (EX-HN3), Zhongwan (CV12), Bilateral Neiguan (PC6), Bilateral Zusanli (ST36), Bilateral Sanyinjiao (SP6), Bilateral Gongsun (SP4), Bilateral Pishu (BL20). Electroacupuncture is applied at bilateral Sanyinjiao (SP6) and bilateral Zusanli (ST36) by connecting them to an electroacupuncture device. The needles are retained for 30 minutes.
Sham Acupuncture: sham acupuncture procedure that mirrors the acupuncture treatment in terms of acupoint selection and treatment schedule. However, instead of actual needle insertion, a blunt-tipped sham needle will be used to apply superficial pressure at the designated acupoints. The design of the sham needle includes a base that allows for simulated insertion, providing patients with a mild sensation of pressure and a visual cue as the needle appears to move toward the skin. This innovative approach ensures that while participants experience a similar tactile sensation, there is no penetration of the skin, distinguishing it clearly from the actual acupuncture treatment.
Chemotherapy: Adjuvant chemotherapy with either the XELOX (capecitabine + oxaliplatin) or SOX (S-1 + oxaliplatin) regimen
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. 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
2. Postoperative pathological diagnosis of gastric cancer, with pathological staging of pII/pIII (American Joint Committee on Cancer, AJCC)
3. No recurrence or metastasis confirmed by imaging examination
4. Performance Status (PS) score of 0-2
5. Age between 18 and 75 years
6. 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
7. Signed informed consent, and the patient voluntarily accepts treatment according to this protocol
Exclusion Criteria:
1. Unable to complete baseline assessment
2. Individuals with a fear of acupuncture
3. Those planning to receive postoperative adjuvant radiotherapy
4. History of blood system diseases, organ transplant history, or those requiring long-term oral immunosuppressants
5. Individuals with implanted cardiac pacemakers
6. Those who have received acupuncture treatment within the past 6 weeks
7. Fever within 3 days prior to enrollment with a temperature above 38°C or clinically significant infections(Subject to enrollment once infection is managed)
8. Currently receiving or having used the investigational drug or device within 4 weeks prior to the first intervention of the study
9. Presence of other primary tumors
10. 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
Primary outcome measure(s)
Disease free survival — 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.
Trial sites (3)
Facility
City
Region
Status
The first affiliated hospital, Sun Yat-sen University
Guangzhou
Guangdong
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou
Guangdong
Sixth Affiliated Hospital ,Sun Yat-sen University
Guangzhou
Guangdong
More Guangzhou University of Traditional Chinese Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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