Status:
ENROLLING_BY_INVITATION
Intestinal Microbiota Transplantation, Radiochemotherapy and Sintilimab in Localized Advanced Colon Cancer
Lead Sponsor:
First Affiliated Hospital of Ningbo University
Conditions:
Localized Advanced Rectal Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The standard treatment for locally advanced rectal cancer is neoadjuvant chemoradiotherapy followed by total mesorectal excision. While Immune checkpoint inhibitors are promising in the treatment of v...
Detailed Description
The incidence rate of colorectal cancer (CRC) ranks among the top three most common cancers in the world, while the mortality rate ranks among the top two. Early symptoms of rectal cancer are not obvi...
Eligibility Criteria
Inclusion
- Must sign the informed consent form with good compliance;
- Age 18 to 75 years ;
- ECOG score 0-1 points;
- Locally advanced rectal adenocarcinoma and TNM clinical stage IIA-IIIC (T3-4/N+);
- The distance between the lower edge of the tumor and the anal margin is less than or equal to 10cm.
- Have not received any anti-tumor treatment in the past (including but not limited to surgery, radiotherapy, chemotherapy, anti vascular therapy, immunotherapy, etc.); 7 The main organ functions well. -
- Exclusion Criteria:
- 1\. Other malignant tumors, including rectal cancer with other pathological types within 5 years; 2. Not using probiotics in the past 2 months; 3. Severe damage to the intestinal barrier, such as sepsis, active gastrointestinal bleeding, perforation, etc.; 4. Weight loss of ≥ 20% within 90 days; 5. Poor nutritional status or PG-SGA score ≥ 9; 6. Severe and/or uncontrolled illnesses.
- Poor blood pressure control (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg)
- ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470ms), and ≥ grade 2 congestive heart failure
- History of interstitial lung disease, non infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute lung diseases
- Active or uncontrolled severe infection (≥ CTCAE level 2 infection)
- Cirrhosis and active hepatitis; Active hepatitis (hepatitis B reference: HBsAg is positive, and the HBV DNA detection value exceeds the upper limit of normal value; Hepatitis C reference: HCV antibody positive and HCV virus titer detection value exceeding the upper limit of normal); Note: Subjects with positive hepatitis B B surface antigen or core antibody and patients with hepatitis C who meet the inclusion conditions need continuous antiviral treatment to prevent virus activation
- Active syphilis patients
- Renal failure requiring hemodialysis or peritoneal dialysis
- History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or organ transplantation 7. Poor control of diabetes (fasting blood glucose \[FBG\]\>10mmol/L) 8. Significant surgical treatment, open biopsy, or significant traumatic injury within 60 days prior to the start of treatment; Or long-term untreated wounds or fractures 9. Serious arterial/venous thrombotic events such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism occurred within 6 months before the start of treatment 10. History of abuse of psychotropic drugs who are unable to quit or have mental disorders 11. History of severe allergies 12. Pregnant or lactating women
Exclusion
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06931808
Start Date
March 1 2025
End Date
August 1 2028
Last Update
April 17 2025
Active Locations (1)
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1
First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315000