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A Randomized Controlled Study of the Efficacy of Oral Lactobacillus Plantarum AS21 on Preoperative Neoadjuvant Chemotherapy and Immunotherapy for Gastric Cancer

A Randomized Controlled Study of the Efficacy of Oral Lactobacillus Plantarum AS21 on Preoperative Neoadjuvant Chemotherapy and Immunotherapy for Gastric Cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094899
Enrollment
Unknown
Registered
2024-12-30
Start date
2024-12-31
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

experimental group:Conventional treatment+AS21

Sponsors

The First Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Radical surgery for gastric cancer has been performed, and pathological biopsy has confirmed gastric adenocarcinoma; (2) Age>= 18 years old and =1; (4) Receiving preoperative neoadjuvant chemotherapy (SOX regimen) plus immunotherapy (sintilimab or tislelizumab).

Exclusion criteria

Exclusion criteria: (1) Functional constipation or diarrhea, digestive tract diseases such as inflammatory bowel disease, severe abdominal distension with intestinal perforation, immune deficiency, sepsis risk; (2) Patients with systemic diseases, severe heart, lung, kidney, liver dysfunction and metabolic diseases, collagen diseases, endocrine diseases or other malignant solid tumors or hematological tumors (leukemia, lymphoma, etc.), have received radiotherapy and chemotherapy, etc.; (3) Use of antidiarrheal drugs, antispasmodics, probiotics or antibiotic treatment within 1 month before enrollment.

Design outcomes

Primary

MeasureTime frame
Short-term efficacy;Gastrointestinal symptoms;Dysbiosis of the gut microbiota and changes in metabolites;

Secondary

MeasureTime frame
Incidence and severity of myelosuppression;Routine blood and blood biochemical indicators;Changes in T cell subsets;Quality of life scores;Incidence of tumor recurrence and metastasis;Disease-free survival and overall survival status of the patient;

Countries

China

Contacts

Public ContactGuan Quanlin

The First Hospital of Lanzhou University

guanql@lzu.edu.cn+86 138 9347 3086

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026