Gastric Cancer, AdenocarcinomaNCT07098026
Shenqi Fuwei Mixture Combined With Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric Cancer
A study testing Shenqi Fuwei Mixture in people with Gastric Cancer, Adenocarcinoma, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
The purpose of this clinical trial is to investigate whether the drug Shenqi Fuwei Mixture is effective for postoperative recurrence and metastasis of gastric cancer. Safety of Shenqi Fuwei Mixture will also be understood. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Adenocarcinoma
- What is being tested?
- Shenqi Fuwei Mixture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 31 Dec 2028
- Phase
- Interventional
- 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
- Gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or cytology;
- Resectable or potentially resectable gastric cancer with clinical stage of cT3-4aN + M0 or cT4bNxM0;
- Patients who are not allowed to receive previous anti-tumor therapy including chemotherapy radiotherapy immunotherapy or targeted therapy; Adequate organ function defined as follows: hematological ANC ≥ 1.5 * 10 ^ 9/L hemoglobin ≥ 9 g/dL platelets ≥ 80 * 10 ^ 9/L albumin ≥ 30 g/L serum bilirubin ≤ 1.5 × ULN AST and ALT ≤ 2.5 × ULN ALP ≤ 2.5 × ULN TBIL ≤ 1.5 × ULN renal serum creatinine < 1.5 × ULN.
- KPS ≥ 70 points;
- 18-75 years old male or female;
- Subjects voluntarily signed a written informed consent form.
Who cannot join
- Associated with distant metastasis;
- Patients with known hypersensitivity or metabolic disorder to fluorouracil or oxaliplatin or known hypersensitivity or intolerance to the study drug; Patients with primary malignant tumors at other sites. Subjects who were disease-free for 5 years or had a history of completely resected non-melanoma skin cancer or successfully treated carcinoma in situ were eligible;
- Gastrointestinal emergencies include: inability to swallow (complete or incomplete) gastrointestinal obstruction gastrointestinal bleeding and gastrointestinal perforation;
- Patients who are pregnant have neurological diseases or mental illness and mental and language disorders;
- Known uncontrolled angina pectoris arrhythmia congestive heart failure or myocardial infarction or a history of cardiac insufficiency within 6 months prior to study enrollment;
- Any concurrent disease or condition that may make the subject unsuitable for study participation or any serious medical condition that may interfere with the subject 's safety;
- Persons who are incapable (legally) or unsuitable for continuing study treatment for ethical/medical reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
About this study
Official title: Shenqi Fuwei Mixture Combined With Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric Cancer: A Multicenter Randomized Controlled Clinical Study
The purpose of this clinical trial is to investigate whether the drug Shenqi Fuwei Mixture is effective for postoperative recurrence and metastasis of gastric cancer. Safety of Shenqi Fuwei Mixture will also be understood. It aims to answer the main questions:
- Shenqi Fuwei Mixture in perioperative combined with neoadjuvant chemotherapy to reduce the recurrence and metastasis of locally advanced gastric cancer after surgery?
- Shenqi Fuwei Mixture in the prevention and treatment of postoperative recurrence and metastasis of gastric cancer dominant population characteristics and efficacy mechanism?
- Exploratory excavation of TCM syndrome, multi-omics combined means to explore the advantages of Shenqi Fuwei Mixture on postoperative recurrence and metastasis of gastric cancer? The researchers will compare the drug Shenqi Fuwei Mixture with placebo (a substance that does not contain drugs and has a similar appearance) to see if the drug Shenqi Fuwei Mixture can prevent and treat recurrence and metastasis of gastric cancer after surgery.
Read more
Participants will:
- Take Shenqi Fuwei Mixture or placebo daily, synchronize with chemotherapy, or until tumor progression or intolerable toxicity
- Visits every 3 weeks for tests and tests
- Their survival status and adverse drug reactions were recorded
- Conditions
- Gastric Cancer, Adenocarcinoma
- Being tested
- Shenqi Fuwei Mixture, Shenqi Fuwei Mixture Placebo
- Keywords
- locally advanced gastric cancer, perioperative, neoadjuvant chemotherapy, Shenqi Fuwei Mixture
- Medical subject headings
- Stomach Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shenqi Fuwei MixtureDrug
Shenqi Fuwei Mixture
Shenqi Fuwei Mixture PlaceboDrug
Shenqi Fuwei Mixture Placebo
| Study group | Role | What they receive |
|---|---|---|
| Shenqi Fuwei Mixture | Experimental | Shenqi Fuwei Mixture Receives: Drug: Shenqi Fuwei Mixture |
| Shenqi Fuwei Mixture Placebo | Placebo comparator | Shenqi Fuwei Mixture Placebo Receives: Drug: Shenqi Fuwei Mixture Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFS
Event-Free Survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Secondary outcomes (9)
Surgical conversion rate
Measured: Binary classification variables were used to calculate the proportion of patients who could undergo surgery, whichever came first, assessed up to 60 months
OS
Overall Survival
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months
Tumor markers
CEA、CA724、CA199、CA125
Measured: "Baseline" or "3 week"
DFS
Disease-Free Survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Infections and complications
Measured: Perioperative/Periprocedural
FACT-Ga Scale
Functional Assessment of Cancer Therapy--Gastric cancer Scale. minimum and maximum values: 0-100, and higher scores mean a better outcome.
Measured: "Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)"
Adverse events
Measured: At the end of Cycle 1 (each cycle is 21 days)
ESAS Scale
Edmonton Symptom Assessment Scale. minimum and maximum values: 0-100, and higher scores mean a better outcome.
Measured: "Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)"
MDASI-TCM Scale
M.D.Anderson Symptom Inventory Traditional Chinese Medicine Scale. minimum and maximum values: 0-100, and higher scores mean a better outcome.
Measured: "Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 May 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric Cancer, AdenocarcinomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, large-sample, randomized, double-blind, placebo-controlled clinical study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098026
- Sponsor's protocol ID
- HNCH-2024KY81
- Status last verified
- Jul 2025
- First submitted
- 15 Jun 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Xu B, Zhang X, Jiao J, Tang Q, Xiong X, Liu Z, He X, Li D. Efficacy and safety of Shenqi Fuwei granule combined with perioperative regimen in the treatment of locally advanced gastric cancer: a randomized, double-blind, placebo-controlled multicenter clinical trial protocol. Front Oncol. 2026 Aug 14;16:1867721. doi: 10.3389/fonc.2026.1867721. eCollection 2026.
PubMed 42666213
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shenqi Fuwei Mixture Combined With Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric Cancer: A Multicenter Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07098026
- Acronym / sponsor ID
- HNCH-2024KY81
- Conditions
- Gastric Cancer, Adenocarcinoma
- Keywords
- locally advanced gastric cancer, perioperative, neoadjuvant chemotherapy, Shenqi Fuwei Mixture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Aug 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.
The purpose of this clinical trial is to investigate whether the drug Shenqi Fuwei Mixture is effective for postoperative recurrence and metastasis of gastric cancer. Safety of Shenqi Fuwei Mixture will also be understood. It aims to answer the main questions:
- Shenqi Fuwei Mixture in perioperative combined with neoadjuvant chemotherapy to reduce the recurrence and metastasis of locally advanced gastric cancer after surgery?
- Shenqi Fuwei Mixture in the prevention and treatment of postoperative recurrence and metastasis of gastric cancer dominant population characteristics and efficacy mechanism?
- Exploratory excavation of TCM syndrome, multi-omics combined means to explore the advantages of Shenqi Fuwei Mixture on postoperative recurrence and metastasis of gastric cancer? The researchers will compare the drug Shenqi Fuwei Mixture with placebo (a substance that does not contain drugs and has a similar appearance) to see if the drug Shenqi Fuwei Mixture can prevent and treat recurrence and metastasis of gastric cancer after surgery.
Participants will:
- Take Shenqi Fuwei Mixture or placebo daily, synchronize with chemotherapy, or until tumor progression or intolerable toxicity
- Visits every 3 weeks for tests and tests
- Their survival status and adverse drug reactions were recorded
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, large-sample, randomized, double-blind, placebo-controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Shenqi Fuwei Mixture | Experimental | Drug: Shenqi Fuwei MixtureShenqi Fuwei Mixture |
| Shenqi Fuwei Mixture Placebo | Placebo comparator | Drug: Shenqi Fuwei Mixture PlaceboShenqi Fuwei Mixture Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or cytology;
- Resectable or potentially resectable gastric cancer with clinical stage of cT3-4aN + M0 or cT4bNxM0;
- Patients who are not allowed to receive previous anti-tumor therapy including chemotherapy radiotherapy immunotherapy or targeted therapy; Adequate organ function defined as follows: hematological ANC ≥ 1.5 * 10 ^ 9/L hemoglobin ≥ 9 g/dL platelets ≥ 80 * 10 ^ 9/L albumin ≥ 30 g/L serum bilirubin ≤ 1.5 × ULN AST and ALT ≤ 2.5 × ULN ALP ≤ 2.5 × ULN TBIL ≤ 1.5 × ULN renal serum creatinine < 1.5 × ULN.
- KPS ≥ 70 points;
- 18-75 years old male or female;
Key exclusion criteria (7 listed)
- Associated with distant metastasis;
- Patients with known hypersensitivity or metabolic disorder to fluorouracil or oxaliplatin or known hypersensitivity or intolerance to the study drug; Patients with primary malignant tumors at other sites. Subjects who were disease-free for 5 years or had a history of completely resected non-melanoma skin cancer or successfully treated carcinoma in situ were eligible;
- Gastrointestinal emergencies include: inability to swallow (complete or incomplete) gastrointestinal obstruction gastrointestinal bleeding and gastrointestinal perforation;
- Patients who are pregnant have neurological diseases or mental illness and mental and language disorders;
- Known uncontrolled angina pectoris arrhythmia congestive heart failure or myocardial infarction or a history of cardiac insufficiency within 6 months prior to study enrollment;
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 |
|---|---|---|
| Shenqi Fuwei MixtureShenqi Fuwei Mixture | Drug | Shenqi Fuwei Mixture |
| Shenqi Fuwei Mixture PlaceboShenqi Fuwei Mixture Placebo | Drug | Shenqi Fuwei Mixture Placebo |
Primary outcome
EFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Event-Free Survival
9 secondary outcomes
Surgical conversion rate
Time frame: Binary classification variables were used to calculate the proportion of patients who could undergo surgery, whichever came first, assessed up to 60 months
OS
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months
Tumor markers
Time frame: "Baseline" or "3 week"
DFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Infections and complications
Time frame: Perioperative/Periprocedural
FACT-Ga Scale
Time frame: "Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)"
Adverse events
Time frame: At the end of Cycle 1 (each cycle is 21 days)
ESAS Scale
Time frame: "Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)"
MDASI-TCM Scale
Time frame: "Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)"
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 1 Aug 2025.
- Derived from this study: PubMed 42666213Xu B, Zhang X, Jiao J, Tang Q, Xiong X, Liu Z, He X, Li D. Efficacy and safety of Shenqi Fuwei granule combined with perioperative regimen in the treatment of locally advanced gastric cancer: a randomized, double-blind, placebo-controlled multicenter clinical trial protocol. Front Oncol. 2026 Aug 14;16:1867721. doi: 10.3389/fonc.2026.1867721. eCollection 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shenqi Fuwei Mixture in people with Gastric Cancer, Adenocarcinoma, run by Hunan Cancer Hospital 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 1 Aug 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Bowen Xu, Dr. (+8618811732383, xubowen@hnca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFS (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months). 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 NCT07098026, which also lists 1 linked publication.
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 1 Aug 2025.