Microbial biomarkers linked to response to pre-surgery therapy for digestive cancers
A Single-center, Exploratory Study on Predicting Neoadjuvant Therapy Efficacy and Prognosis in Pan-gastrointestinal Cancer Patients Based on Intratumoral Microbiome Characteristics and Their Functional Targets.
Tianjin Medical University Cancer Institute and Hospital · NCT07263620
This project will test whether microbes can predict how adults with esophageal, gastric, pancreatic, or colorectal cancer respond to neoadjuvant (pre-surgery) therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT07263620 on ClinicalTrials.gov |
What this trial studies
This observational study will collect microbial samples and clinical data from adults (18–80) with biopsy-confirmed esophageal, gastric, pancreatic, or colorectal cancer who are planned for neoadjuvant therapy at Tianjin Medical University Cancer Institute and Hospital. Eligible patients have borderline resectable or locally advanced disease and will undergo standard-of-care neoadjuvant treatment while investigators collect serial specimens and treatment outcome data. Microbial profiles will be compared between responders and non-responders using molecular sequencing and statistical modeling to identify candidate biomarkers associated with treatment efficacy. The study does not introduce experimental treatments and follows routine clinical management and follow-up.
Who should consider this trial
Good fit: Adults aged 18–80 with biopsy-confirmed esophageal, gastric, pancreatic, or colorectal cancer who are scheduled for neoadjuvant therapy for borderline resectable or locally advanced disease and meet organ function and general health requirements.
Not a fit: Patients with distant metastases, rapid recurrence after prior surgery, significant organ dysfunction, severe cardiovascular or psychiatric comorbidities, or those not receiving neoadjuvant therapy are unlikely to benefit from the study findings.
Why it matters
Potential benefit: If successful, this could help doctors predict who is most likely to benefit from neoadjuvant therapy and personalize treatment plans.
How similar studies have performed: Prior research linking the microbiome to cancer treatment response has shown promising signals—especially for immunotherapy—but applying microbial biomarkers to predict neoadjuvant therapy outcomes in digestive cancers remains early and exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years and ≤80 years * Pathologically confirmed diagnosis (via preoperative biopsy) of pancreatic cancer, gastric cancer, colorectal cancer, or esophageal cancer * Imaging evaluation indicates borderline resectable or locally advanced disease, and the patient is scheduled to receive neoadjuvant therapy according to treatment guidelines * Expected survival time \> 3 months * Hematologic function: neutrophil count \> 1.5 × 10⁹/L * Liver function:Total serum bilirubin ≤ 1.5 × upper limit of normal (ULN)；ALT and AST ≤ 2 × ULN * Renal function: serum creatinine ≤ 1.5 × ULN * No severe cardiovascular or cerebrovascular comorbidities and no psychiatric disorders Exclusion Criteria: * Physically unfit to undergo neoadjuvant chemotherapy * Local recurrence or distant metastasis occurring within 1 month after surgery * Impaired vital organ function, including but not limited to: Heart failure (NYHA Class III-IV); Myocardial infarction within the past 6 months; Severe arrhythmia; Respiratory failure * Presence of another primary malignancy diagnosed within the past 5 years * Pregnant or breastfeeding * Inability to complete follow-up * Active infection * Severe constipation or sudden changes in bowel habits within the past 3 months * Significant changes in dietary habits (e.g., meat-vegetable balance, meal timing, or frequency) within the past 3 months * Medication history within the past 3 months including:Use of NSAIDs, immunosuppressants, antibiotics, traditional Chinese medicine, probiotics, or corticosteroids for ≥1 week; Use of proton pump inhibitors (PPIs) for more than 1 week within 1 month prior to sampling * Refusal to sign the informed consent form
Where this trial is running
Tianjin
- Patients with esophageal, pancreatic, gastric, or colorectal cancer who are scheduled to receive neoadjuvant therapy — Tianjin, China (RECRUITING)
Study contacts
- Study coordinator: Haorui Li
- Email: haoruili1998@126.com
- Phone: 86-022-23340123-3070
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Digestive System Malignancies