Clinical trial · Interventional
Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody for Second-line Treatment of HER2 Negative, pMMR/MSS Advanced Gastric Cancer
Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody for Second-line Treatment of HER2 Negative, pMMR/MSS Advanced Gastric Cancer: a Prospective, Open-labeled, Single-arm, Phase Ⅱ Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There are several basic findings in the previous studies: The levels of renin and aldosterone in the blood of cancer patients vary greatly among individuals, and the baseline levels of some patients are relatively higher than others; The elevated levels of renin and aldosterone in the blood are positively correlated with the higher malignancy, drug resistance and progression of gastric cancer; Electroacupuncture stimulation of relevant acupoints can effectively down-regulate the levels of renin and aldosterone in the blood; Electroacupuncture stimulation of relevant acupoints can effectively activate the function of the immune system. Based on these findings, the present clinical trial aim to evaluated the efficacy and safety of electroacupuncture combined with chemotherapy and PD-1 Antibody for the treatment of specific type of gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody for Second-line Treatment of HER2 Negative, pMMR/MSS Advanced Gastric Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EA+Chemo+IO
- description
- Electroacupuncture (EA) Combined With Paclitaxel Protein-bound (Chemo) and PD-1 Antibody (IO) for Second-line Treatment of HER2 Negative, pMMR/MSS Advanced Gastric Cancer. Electroacupuncture stimulates specific acupoints(dense-sparse wave,30min)d0, d1, d7, d8 + Paclitaxel Protein-bound (125mg/m2) d1, d8 + PD-1 Antibody (not limited to specific drugs,dosages should be calculated according to corresponding drug instructions) d1, Q3W.
- interventionNames
- Combination Product: Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 2 years
- description
- The proportion of patients whose tumors have shrunk to the expected value and can persist until the expected minimum time limit requirement according to the RECIST criteria
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Patients must meet the following study enrollment criteria: Age ≥18 years old and ≤75 years old; Pathology and imaging confirmed advanced gastric cancer with HER2 negative and pMMR/MSS; Progression after first-line chemotherapy with fluorouracil and platinum-based regimens and ±PD-1 monoclonal antibody treatment, second-line treatment is planned; The ECOG score is 0-2; Life expectancy \> 3 months; Willing and able to accept follow-up until death or the end of the study or the termination of the study; The hematological function is normal (platelets \> 80×10\^9/L; White blood cells \> 3×10\^9/L; Neutrophils \> 1.5×10\^9/L; Serum bilirubin ≤1.5 times the upper limit of normal value (ULN), transaminase ≤5 times ULN; There was no ascites, the coagulation function was normal, and the albumin was ≥30g/L; The Child-Push classification of liver function is grade A; Serum creatinine is less than the upper limit of the normal value (ULN), or the calculated creatinine clearance rate is \> 50ml/min (using the Cockcroft-Gault formula) ; Exclusion Criteria: Patients meeting any of the following criteria will be excluded from the study: The primary tumor recurred; Severe arterial embolism or ascites; There is a tendency to bleed or coagulation disorder; Hypertensive crisis or hypertensive encephalopathy; Severe and uncontrollable systemic complications such as infections or diabetes; Clinical severe cardiovascular diseases such as cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), hypertension that remains uncontrolled after appropriate drug treatment, unstable angina pectoris, congestive heart failure (NYHA grades 2-4), and arrhythmias requiring drug treatment; Have suffered from or whose physical examination shows central nervous system diseases (such as primary brain tumors, epilepsy that cannot be controlled by standard treatment, any history of brain metastases or strokes); Have suffered from other malignant tumors in the past five years (excluding basal cell carcinoma of the skin and/or carcinoma in situ of the cervix after radical resection); Be allergic to any drug in the study; Pregnant and lactating women; There are any other diseases, functional disorders caused by metastatic lesions, or suspected disorders found during physical examinations, suggesting that there may be contraindications to the use of the studied drug or putting the patient at high risk of treatment-related complications; Unable or unwilling to comply with the research protocol;
References
Publications (5)
- BACKGROUNDHan Z, Cheng S, Dai D, Kou Y, Zhang X, Li F, Yin X, Ji J, Zhang Z, Wang X, Zhu N, Zhang Q, Tan Y, Guo X, Shen L, Peng Z. The gut microbiome affects response of treatments in HER2-negative advanced gastric cancer. Clin Transl Med. 2023 Jul;13(7):e1312. doi: 10.1002/ctm2.1312. PMID 37381590
- BACKGROUNDRha SY, Oh DY, Yanez P, Bai Y, Ryu MH, Lee J, Rivera F, Alves GV, Garrido M, Shiu KK, Fernandez MG, Li J, Lowery MA, Cil T, Cruz FM, Qin S, Luo S, Pan H, Wainberg ZA, Yin L, Bordia S, Bhagia P, Wyrwicz LS; KEYNOTE-859 investigators. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Nov;24(11):1181-1195. doi: 10.1016/S1470-2045(23)00515-6. Epub 2023 Oct 21. PMID 37875143
- BACKGROUNDLee HS, Kim JY. Effects of acupuncture on blood pressure and plasma renin activity in two-kidney one clip Goldblatt hypertensive rats. Am J Chin Med. 1994;22(3-4):215-9. doi: 10.1142/S0192415X94000279. PMID 7872233
- BACKGROUNDZhang M, Zhu Y, Wang J, Li Y, Hua Z. Association between acupuncture and grade 1 hypertension: A systematic review and meta-analysis. Complement Ther Clin Pract. 2022 Nov;49:101649. doi: 10.1016/j.ctcp.2022.101649. Epub 2022 Aug 7. PMID 35963138
- BACKGROUNDSugimoto M, Yamaoka Y, Shirai N, Furuta T. Role of renin-angiotensin system in gastric oncogenesis. J Gastroenterol Hepatol. 2012 Mar;27(3):442-51. doi: 10.1111/j.1440-1746.2011.06964.x. PMID 22114933