NCT06486220

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Yun-fei Xia · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Experimental group (PFLL + PD-1 + FMT) : 5-Fu 200mg/ m2 /d, D1-30 + cisplatin 80mg/ m2, d1, 28 or D1-3, 28-30 + triplizumab 240mg, d1, 22 + FMT 10 capsules in the morning, middle and evening, D-5-3, 11-13, 38-40;Every 60 days/cycle, PFLL + PD-1 + FMT is given for a maximum of 6 cycles. Control group (PFLL + PD-1) : 5-Fu 200mg/ m2 /d, D1-30 + cisplatin 80mg/ m2, d1, 28 or D1-3, 28-30 + triplizumab 240mg, d1, 22;PFLL + PD-1 is given a maximum of 6 cycles per 60 days/cycle.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Intestinal bacteria freeze-dried powder capsules	Oral healthy intestinal bacteria freeze-dried powder capsules, tid

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-07-01
• Completion: 2026-07-01
• First posted: 2024-07-03
• Last updated: 2024-07-03