Shenqi Fuwei Mixture combined with neoadjuvant chemotherapy for locally advanced gastric cancer

Shenqi Fuwei Mixture Combined With Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric Cancer: A Multicenter Randomized Controlled Clinical Study

We will see if adding Shenqi Fuwei Mixture to perioperative neoadjuvant chemotherapy can reduce recurrence and spread in adults with locally advanced gastric adenocarcinoma.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 286 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hunan Cancer Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT07098026 on ClinicalTrials.gov

What this trial studies

This is a randomized, placebo‑controlled interventional trial testing Shenqi Fuwei Mixture given around the time of neoadjuvant chemotherapy and surgery for locally advanced gastric cancer. Participants receive either the Shenqi Fuwei Mixture or a matching placebo together with standard neoadjuvant chemotherapy, with follow‑up after surgery to track recurrence, metastasis, and safety. The trial also includes exploratory analyses of traditional Chinese medicine syndromes and multi‑omics biomarkers to try to identify which patients may benefit and potential mechanisms. Eligibility requires resectable or potentially resectable disease, no prior anti‑tumor therapy, and adequate organ function.

Who should consider this trial

Good fit: Adults 18–75 with resectable or potentially resectable locally advanced gastric or gastroesophageal junction adenocarcinoma (eg, cT3–4aN+, M0 or cT4bNxM0), no prior systemic anti‑tumor therapy, adequate organ function, and KPS ≥70 are the intended participants.

Not a fit: Patients with distant metastases, prior chemotherapy/radiotherapy/immunotherapy/targeted therapy, significant organ dysfunction, known hypersensitivity to study drugs, or outside the 18–75 age range are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If effective, the treatment could lower the chance of postoperative recurrence and metastasis and improve longer‑term outcomes after surgery.

How similar studies have performed: Traditional Chinese medicine combined with chemotherapy has produced mixed, limited high‑quality evidence to date, and this specific Shenqi Fuwei Mixture has not been established in large rigorous randomized trials.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Changsha, Hunan

• Hunan Cancer Hospital — Changsha, Hunan, China (RECRUITING)

Study contacts

• Study coordinator: Bowen Xu, Dr.

Conditions: Gastric Cancer, Adenocarcinoma, locally advanced gastric cancer, perioperative, neoadjuvant chemotherapy, Shenqi Fuwei Mixture