Status:
ENROLLING_BY_INVITATION
A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Oral Teslanbaicin in Patients With Radiation Proctitis
Lead Sponsor:
The First Affiliated Hospital of Xinxiang Medical College
Conditions:
Safety
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Radiation Proctitis refers to rectal radiation injury caused by radiotherapy for pelvic malignancies. It is classified into Acute Radiation Proctitis (ARP) and Chronic Radiation Proctitis (CRP) based ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT06974123
Start Date
October 15 2024
End Date
December 31 2026
Last Update
May 15 2025
Active Locations (1)
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1
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China