A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Oral Teslanbaicin in Patients With Radiation Proctitis

Launched by THE FIRST AFFILIATED HOSPITAL OF XINXIANG MEDICAL COLLEGE · May 8, 2025

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Voluntary participation with signed informed consent form, good compliance, ability to cooperate with diagnosis, treatment, and follow-up; Age ≥18 years (inclusive), regardless of gender; Pathologically confirmed pelvic malignancies (via histology or cytology) requiring pelvic radiotherapy, clinically diagnosed with Grade 1-2 radiation proctitis (per CTCAE criteria); Karnofsky Performance Status (KPS) score ≥60; Expected survival period ≥6 months;
• Normal function of major organs, with laboratory values meeting the following criteria:
• • Absolute neutrophil count (ANC) ≥1.5×10\^9/L Platelets ≥75×10\^9/L Hemoglobin ≥90g/L Creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) \>60 mL/min/1.73m² (Cockcroft-Gault formula) Total bilirubin \<1.5×ULN AST/ALT \<2.5×ULN (≤5×ULN for subjects with liver metastasis) Albumin (ALB) ≥30g/L INR or prothrombin time (PT) \<1.5×ULN (if on anticoagulant therapy, PT must be within the intended therapeutic range).
• Exclusion Criteria:
• • Severe internal and external hemorrhoids; Allergy to any component of the investigational drug; Comorbid inflammatory bowel disease, irritable bowel syndrome, chronic gastrointestinal bleeding, or other diseases potentially associated with chronic diarrhea symptoms; Specific dietary habits prone to causing intestinal symptoms that cannot be modified; Personality or psychiatric disorders, individuals lacking civil capacity or with limited civil capacity; Medical history, conditions, treatments, or laboratory abnormalities that may interfere with trial results or hinder full participation; Other circumstances deemed unsuitable for study participation by the investigator.