Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody for Second-line Treatment of HER2 Negative, pMMR/MSS Advanced Gastric CancerPhase 2EAPPANCT06992024
Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody for Second-line Treatment of HER2 Negative, pMMR/MSS Advanced Gastric Cancer
A Phase 2 study testing Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody in people with Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody for Second-line Treatment of HER2 Negative, pMMR/MSS Advanced Gastric Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody for Second-line Treatment of HER2 Negative, pMMR/MSS Advanced Gastric Cancer
- What is being tested?
- Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 1 Apr 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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) ;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: 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
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.
Read the detailed description
The number of new cases of gastric cancer ranks fifth among all cancers worldwide, and the number of deaths from gastric cancer ranks fourth. In 2020, the number of global deaths from gastric cancer was close to 770,000. Gastric cancer is a common malignant tumor in China. In 2020, the number of new cases ranked second and the number of deaths ranked third. The number of new cases was approximately 480,000, accounting for 43.9% of the global total, and the number of deaths was about 370,000, accounting for 48.6% of the global total. Moreover, gastric cancer with clinical stages III-IV accounted for about 60%. For HER2-negative advanced gastric cancer, chemotherapy based on platinum-based, fluorouracil and paclitaxel has been regarded as the standard treatment approach in the past few decades. However, the effect of chemotherapy is extremely limited, and the objective response rate of first-line treatment is only 40%-50%. With the clinical application of immune checkpoint inhibitors, the treatment strategies for gastric cancer have undergone revolutionary changes. However, the objective response rate of immune checkpoint inhibitor monotherapy for advanced gastric cancer is only 11%-15% [1]. This means that most patients find it difficult to benefit from monotherapy with immune checkpoint inhibitors. Chemotherapy combined with immune checkpoint inhibitors is a feasible method to overcome drug resistance. A phase III, multicenter international study KEYNOTE 859 demonstrated that the combination of immune checkpoint inhibitor pembrolizumab (a PD-1 monoclonal antibody) and chemotherapy as first-line treatment for locally advanced unresectable or metastatic HER2-negative gastric cancer could significantly prolong the median overall survival time (OS) of patients compared with placebo combined with chemotherapy (P < 0.0001). Maintain a better quality of life score, and Chinese patients can benefit from pembrolizumab combined with chemotherapy (median OS 15.9 months, objective response rate (ORR) 69%) [2]. Therefore, in December 2023, pembrolizumab was approved in China for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in combination with fluorouracil and platinum-based chemotherapy. Her2-negative, complete mismatch repair gene/microsatellite stable (pMMR/MSS) advanced gastric cancer is a difficulty in the treatment of gastric cancer. Especially, there are no large-scale phase III clinical research data for second-line treatment after the progression of first-line treatment. According to the latest version of the Chinese CSCO diagnosis and treatment guidelines, for this type of patients, chemotherapy ± immune checkpoint inhibitors (such as PD-1 monoclonal antibodies, etc.) are recommended as the first-line treatment. After the progression of the first-line treatment, the second-line treatment is recommended as either monotherapy with paclitaxel or monotherapy with irinotecan or paclitaxel combined with the anti-vascular targeted drug ramoxifumab. Considering the economic situation of patients in the real world, Most patients can only receive monotherapy, and the control effect of monotherapy on the disease is extremely limited. There is no large-scale clinical research data on whether chemotherapy combined with PD-1 monoclonal antibody can bring benefits to patients in the second-line treatment of advanced gastric cancer.
Electroacupuncture therapy, as an important treatment method in traditional Chinese medicine, has been widely proven to improve various diseases by regulating the levels of multiple hormones in the body and regulating the immune function. In previous studies, our research group and other research groups found that electroacupuncture stimulation of specific acupoints can significantly down-regulate the levels of blood renin and aldosterone, and the effect is particularly obvious for patients whose baseline levels of blood renin and aldosterone are higher than the normal range [3, 4]. The levels of renin and aldosterone in the blood have been confirmed to be positively correlated with the malignancy degree and progression rate of gastric cancer [5].
Based on the above previous findings, this study proposes a new treatment strategy for HER2-negative advanced gastric cancer patients with pMMR/MSS who progressed after first-line chemotherapy with fluorouracil and platinum-based regimens ±PD-1 monoclonal antibody treatment, and adopts the second-line electroacupuncture + Paclitaxel Protein-bound +PD-1 monoclonal antibody regimen. The efficacy and safety of this regimen are intended to be evaluated.
- Being tested
- Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody
- Keywords
- electroacupuncture, paclitaxel protein-bound, PD-1 antibody, HER2 negative, pMMR/MSS advanced gastric cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 AntibodyCombination product
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. If the diseases are well controlled after 6 cycles, maintenance treatment, namely Electroacupuncture stimulates specific acupoints（dense-sparse wave，30min）d0, d1 + PD-1 Antibody (not limited to specific drugs，dosages should be calculated according to corresponding drug instructions) d1, Q3W, will be continually conducted until the diseases progress.
| Study group | Role | What they receive |
|---|---|---|
| EA+Chemo+IO | Experimental | 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. Receives: Combination Product: Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
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
Measured: 2 years
Secondary outcomes (3)
Disease control rate (DCR)
The proportion of patients whose tumors were classified as CR (complete response), PR (partial response), and SD (stable disease) according to the RECIST criteria
Measured: 2 years
Progression-free survival time (PFS)
The time from the start of randomization to tumor progression or death
Measured: 2 years
PFS rate
The proportion of patients who did not experience tumor progression or death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Apr 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody for Second-line Treatment of HER2 Negative, pMMR/MSS Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody for Second-line Treatment of HER2 Negative, pMMR/MSS Advanced Gastric Cancer.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992024
- Sponsor's protocol ID
- 20250554
- Acronym
- EAPPA
- Status last verified
- Apr 2025
- First submitted
- 19 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Han 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.
PubMed 37381590Rha 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.
PubMed 37875143Lee 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.
PubMed 7872233Zhang 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.
PubMed 35963138Sugimoto 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.
PubMed 22114933
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06992024
- Acronym / sponsor ID
- EAPPA / 20250554
- Keywords
- electroacupuncture, paclitaxel protein-bound, PD-1 antibody, HER2 negative, pMMR/MSS advanced gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The number of new cases of gastric cancer ranks fifth among all cancers worldwide, and the number of deaths from gastric cancer ranks fourth. In 2020, the number of global deaths from gastric cancer was close to 770,000. Gastric cancer is a common malignant tumor in China. In 2020, the number of new cases ranked second and the number of deaths ranked third. The number of new cases was approximately 480,000, accounting for 43.9% of the global total, and the number of deaths was about 370,000, accounting for 48.6% of the global total. Moreover, gastric cancer with clinical stages III-IV accounted for about 60%. For HER2-negative advanced gastric cancer, chemotherapy based on platinum-based, fluorouracil and paclitaxel has been regarded as the standard treatment approach in the past few decades. However, the effect of chemotherapy is extremely limited, and the objective response rate of first-line treatment is only 40%-50%. With the clinical application of immune checkpoint inhibitors, the treatment strategies for gastric cancer have undergone revolutionary changes. However, the objective response rate of immune checkpoint inhibitor monotherapy for advanced gastric cancer is only 11%-15% [1]. This means that most patients find it difficult to benefit from monotherapy with immune checkpoint inhibitors. Chemotherapy combined with immune checkpoint inhibitors is a feasible method to overcome drug resistance. A phase III, multicenter international study KEYNOTE 859 demonstrated that the combination of immune checkpoint inhibitor pembrolizumab (a PD-1 monoclonal antibody) and chemotherapy as first-line treatment for locally advanced unresectable or metastatic HER2-negative gastric cancer could significantly prolong the median overall survival time (OS) of patients compared with placebo combined with chemotherapy (P < 0.0001). Maintain a better quality of life score, and Chinese patients can benefit from pembrolizumab combined with chemotherapy (median OS 15.9 months, objective response rate (ORR) 69%) [2]. Therefore, in December 2023, pembrolizumab was approved in China for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in combination with fluorouracil and platinum-based chemotherapy. Her2-negative, complete mismatch repair gene/microsatellite stable (pMMR/MSS) advanced gastric cancer is a difficulty in the treatment of gastric cancer. Especially, there are no large-scale phase III clinical research data for second-line treatment after the progression of first-line treatment. According to the latest version of the Chinese CSCO diagnosis and treatment guidelines, for this type of patients, chemotherapy ± immune checkpoint inhibitors (such as PD-1 monoclonal antibodies, etc.) are recommended as the first-line treatment. After the progression of the first-line treatment, the second-line treatment is recommended as either monotherapy with paclitaxel or monotherapy with irinotecan or paclitaxel combined with the anti-vascular targeted drug ramoxifumab. Considering the economic situation of patients in the real world, Most patients can only receive monotherapy, and the control effect of monotherapy on the disease is extremely limited. There is no large-scale clinical research data on whether chemotherapy combined with PD-1 monoclonal antibody can bring benefits to patients in the second-line treatment of advanced gastric cancer.
Electroacupuncture therapy, as an important treatment method in traditional Chinese medicine, has been widely proven to improve various diseases by regulating the levels of multiple hormones in the body and regulating the immune function. In previous studies, our research group and other research groups found that electroacupuncture stimulation of specific acupoints can significantly down-regulate the levels of blood renin and aldosterone, and the effect is particularly obvious for patients whose baseline levels of blood renin and aldosterone are higher than the normal range [3, 4]. The levels of renin and aldosterone in the blood have been confirmed to be positively correlated with the malignancy degree and progression rate of gastric cancer [5].
Based on the above previous findings, this study proposes a new treatment strategy for HER2-negative advanced gastric cancer patients with pMMR/MSS who progressed after first-line chemotherapy with fluorouracil and platinum-based regimens ±PD-1 monoclonal antibody treatment, and adopts the second-line electroacupuncture + Paclitaxel Protein-bound +PD-1 monoclonal antibody regimen. The efficacy and safety of this regimen are intended to be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody for Second-line Treatment of HER2 Negative, pMMR/MSS Advanced Gastric Cancer.
| Arm | Type | Receives |
|---|---|---|
| EA+Chemo+IO | Experimental | Combination Product: Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 AntibodyElectroacupuncture (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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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) ;
Key exclusion criteria (2 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 AntibodyElectroacupuncture (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. If the diseases are well controlled after 6 cycles, maintenance treatment, namely Electroacupuncture stimulates specific acupoints（dense-sparse wave，30min）d0, d1 + PD-1 Antibody (not limited to specific drugs，dosages should be calculated according to corresponding drug instructions) d1, Q3W, will be continually conducted until the diseases progress. | Combination product | EA+Chemo+IO |
Primary outcome
Objective response rate (ORR)
Time frame: 2 years
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
3 secondary outcomes
Disease control rate (DCR)
Time frame: 2 years
Progression-free survival time (PFS)
Time frame: 2 years
PFS rate
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Background: PubMed 37381590Han 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.
- Background: PubMed 37875143Rha 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.
- Background: PubMed 7872233Lee 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.
- Background: PubMed 35963138Zhang 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.
- Background: PubMed 22114933Sugimoto 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody in people with Electroacupuncture Combined With Paclitaxel Protein-bound and PD-1 Antibody for Second-line Treatment of HER2 Negative, pMMR/MSS Advanced Gastric Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06992024, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.