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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hunan Cancer Hospital
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Bowen Xu, Dr.
• Email: xubowen@hnca.org.cn
• Phone: +8618811732383

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Precision navigation to boost cancer screening participation in high-risk communities

  This study tests whether a personalized navigation program helps adults aged 45–74 in Chinese communities who are at high risk for several cancers to complete recommended free cancer screenings.

  Recruiting at 3 sites Hunan Cancer Hospital · Huaihua, Hunan and 2 other locations · NCT07676383

• Firmonertinib with definitive radiotherapy for unresectable Stage III NSCLC with EGFR uncommon mutations

  This trial tests whether adding Firmonertinib to definitive radiotherapy helps people with unresectable Stage III NSCLC that has uncommon EGFR mutations.

  Recruiting Phase 2 Hunan Cancer Hospital · Changsha, Hunan · NCT07314216

• Treatment options after targeted therapy stops working in advanced breast cancer

  This study will see how well different treatments work for people with advanced breast cancer who have stopped responding to CDK4/6 inhibitors, PIK3CA inhibitors, or T-DXd.

  Recruiting Hunan Cancer Hospital · Changsha, Hunan · NCT07073755

• Using immunonutrition to reduce esophagitis in lung cancer patients undergoing radiotherapy

  This study is testing if a special nutritional drink can help lung cancer patients undergoing radiation therapy experience less throat irritation.

  Recruiting at 6 sites Phase 3 Hunan Cancer Hospital · Changsha, Hunan and 5 other locations · NCT06840704

• Combining low-dose radiotherapy with chemoimmunotherapy for nasopharyngeal carcinoma with liver metastasis

  This study is testing whether adding low-dose radiation to chemotherapy and immunotherapy can help people with nasopharyngeal cancer that has spread to the liver feel better and improve their treatment results.

  Recruiting at 8 sites Phase 2 Hunan Cancer Hospital · Changsha, Hunan and 7 other locations · NCT06788002

• Using Trilaciclib to Protect Bone Marrow in Head and Neck Cancer Patients After Surgery

  This study is testing if adding a new drug called trilaciclib to standard treatment after surgery can help protect the bone marrow of patients with advanced head and neck cancer from the harmful effects of chemotherapy.

  Recruiting Phase 2 Hunan Cancer Hospital · Changsha, Hunan · NCT06752798

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.