The incidence of chemotherapy-induced diarrhea (CID) is closely related to the types of anticancer drugs. Combination chemotherapy regimens such as fluorouracil derivatives and irinotecan, as well as tyrosine kinase inhibitors like neratinib, are associated with a high severity and incidence of diarrhea. These All antineoplastic agents can induce intestinal epithelial cell apoptosis, damage the intestinal mucosa, subsequently reduce the absorption surface area, and thereby lead to diarrhea. Recent literature has indicated that Bacteroides fragilis may be a candidate drug for the treatment and prevention of CID. This study intends to conduct a randomized controlled trial to determine the efficacy and mechanism of action of inactivated Bacteroides fragilis (SK10) in the prevention of chemotherapy-induced diarrhea (CID).
Voluntarily sign the informed consent form, be able to comply with the protocol and have the capacity to complete relevant procedures.
Aged ≥ 18 years old (based on the date of signing the ICF), regardless of gender.
Patients with malignant tumors confirmed by pathology or cytology.
Cohort 1: Patients with advanced colorectal cancer receiving the FOLFIRI regimen (irinotecan + fluorouracil + leucovorin);
History of altered bowel habits or abnormal stool characteristics prior to screening that, in the investigator's opinion, would preclude subsequent efficacy evaluation; or use of laxatives within 7 days prior to randomization; or use of antidiarrheal agents within 48 hours prior to randomization.
Complicated with diseases causing diarrhea, including but not limited to inflammatory bowel disease (e.g., ulcerative colitis and Crohn's disease), suspected or confirmed infectious diarrhea, irritable bowel syndrome, celiac disease, etc.
Receipt of any chemotherapeutic agents or PD-1 antibodies other than the chemotherapy/treatment regimen specified in the protocol during the trial.
Concurrent abdominopelvic radiotherapy during the trial period; or unresolved radiotherapy-induced enteritis caused by previous abdominopelvic radiotherapy.