drugset / Trial / NCT06486220

PFLL Combined With PD-1 Antibody With or Without FMT for Oligometastatic NPC,a Phase III ,Open, Randomized Clinical Trial.

NCT06486220 ↗

Phase 3 Unknown 96 enrolled Yun-fei Xia
RandomizedParallel-groupOpen-labelTreatment

Summary

There is a correlation between gut microbiota and immunotherapy reactivity, and regulating gut microbiota through FMT can prevent primary resistance to immune checkpoint inhibitors and further improve the effectiveness of tumor immunotherapy.Therefore, on the basis of previous studies, this study intends to explore whether intestinal flora transplantation can improve the anti-tumor efficacy of low-dose long term 5-FU pumping ("old fire soup") therapy combined with immunotherapy and reduce the occurrence of toxic side effects in patients with metastatic nasopharyngeal carcinoma.

Timeline

Start
2024-07-01
Primary completion
2025-07-01
Completion
2026-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Intestinal bacteria freeze-dried powder capsules Unknown 10 unknown Oral