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NCT06992024Active, not recruitingPhase 2

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 · Last updated 4 Jun 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
25 (estimated)
First submitted
19 May 2025
Start date
1 Apr 2025
Primary completion date
31 Mar 2026
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
NCT number
NCT06992024

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 25
  • From 1 Apr 2025 to the primary completion date, 31 Mar 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other

  • Patients meeting any of the following criteria will be excluded from the study:

Who the study is looking for

  • 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) ;

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Second Affiliated Hospital of Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.