digestive tract tumor
Conditions
Interventions
Standard anti-tumor treatment group:Nil
Fecal bacteria transplantation therapy combined with standard anti-tumor therapy group:Nil
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, no gender limit; 2. Patients with digestive tract tumors diagnosed by histopathology or cytology, such as advanced esophageal cancer, gastric cancer, liver cancer, pancreatic cancer, and colorectal cancer; 3. The expected survival period is 6 months and can receive long-term follow-up; 4. The ECOG-PS score is 0-1; 5. No more than 3 lesions; 6. The primary tumor is intended to receive fecal bacteria transplantation combined with radiotherapy and chemotherapy, targeted or immunotherapy (research group); the primary tumor has previously only received standard anti-tumor therapy such as radiotherapy and chemotherapy, targeted or immunotherapy (control group) ; 7. Sufficient organ function; 8. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors have been diagnosed in the past 5 years, except for skin basal cell carcinoma, skin squamous cell carcinoma that have been effectively treated, or cervical cancer in situ and breast cancer that have been effectively removed; 2. Concomitant infections of extraintestinal organs, such as pneumonia, peritonitis, and pleural abscess, need to be treated with antibiotics; 3. Patients who have received or are receiving other biological treatments in the past; 4. It has been proved to be allergic to any component of the test drug and its excipients; 5. There is a history or evidence of interstitial lung disease or non-infectious pneumonia treated with corticosteroids, or any active pneumonia found on a chest CT scan; 6. Poorly controlled severe heart disease, liver and kidney dysfunction, severe anemia, multiple lymphadenopathy, leukopenia, etc.; 7. Congenital or acquired immune deficiency or history of organ transplantation, active hepatitis B or C, or tuberculosis positive; patients with inactive hepatitis B need to take antiviral drugs at the same time; 8. Patients who are pregnant or have pregnancy plans; 9. According to the judgment of the investigator, patients who are not suitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median Progression Free Survival;Median Overall Survival; | — |
Countries
China
Contacts
Public ContactChen Yongshun
Renmin Hospital of Wuhan University
Outcome results
None listed