drugset / Trial / NCT06725082

Impact of Recombinant Humanized Type III Collagen on the Immediate and Long-term Effects of Breast Tumor Surgery

NCT06725082

Phase 1 Recruiting 30 enrolled Peking University People's Hospital
RandomizedParallel-groupDouble-blindOther

Summary

Breast tumors, particularly breast cancer, are increasingly prevalent in China, with a noticeable trend towards younger ages. Preliminary research indicates that Type III Collagen (COL3) plays a crucial role in tissue and organ protection within the tumor microenvironment and can inhibit tumor progression through microenvironmental remodeling. However, there are no clinical studies related to COL3 in breast tumors. This project aims to initiate a multicenter, prospective, randomized, open-label, parallel-controlled trial by locally administering recombinant humanized Type III Collagen (rhCOL3) to patients undergoing breast tumor surgery. The study will observe the incidence of perioperative complications after rhCOL3 injection, as well as changes in aesthetic outcomes and tumor-related pathological indicators following breast tumor surgery with local rhCOL3 injection. The goal is to establish a targeted rhCOL3 local injection therapy with dual functions of local protection and synergistic treatment, providing a new strategy for the treatment of breast tumors.

Timeline

Start
2024-12-01
Primary completion
2025-12-30
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant Humanized Type III Collagen Protein / enzyme biologic 4 mg/ml Other

Indications