Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody for Second-line Treat… (NCT06992024) | Clinical Trial Compass
Active — 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
China25 participantsStarted 2025-04-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR)
Timeframe: 2 years
Trial details
NCT IDNCT06992024
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University