NCT07098026Recruiting
Shenqi Fuwei Mixture Combined With Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric Cancer
Shenqi Fuwei Mixture Combined With Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric Cancer: A Multicenter Randomized Controlled Clinical Study
Source: ClinicalTrials.gov · Last updated 1 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 286 (estimated)
- First submitted
- 15 Jun 2025
- Start date
- 1 May 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Hunan Cancer Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07098026
What you commit to
- Study type: Interventional
- Planned participants: 286
- From 1 May 2025 to the primary completion date, 31 Dec 2028
- 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
- 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;
Other illness
- 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;
Other
- Associated with distant metastasis;
- Persons who are incapable (legally) or unsuitable for continuing study treatment for ethical/medical reasons.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.