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RECRUITING
NCT06657690
PHASE2

Irinotecan Liposome Combined with S-1 in PD-1/L1 Inhibitor Refractory Recurrent or Metastatic NPC

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm Phase 2 study to evaluate the efficacy and safety of Irinotecan Liposome injection combined with S-1 in patients with recurrent (unable to local curative treatment) or metastatic NPC who failed at least first-line anti-PD-1/L1.

Official title: The Efficacy and Safety of Irinotecan Liposome Combined with S-1 in PD-1/L1 Inhibitor Refractory Recurrent or Metastatic Nasopharyngeal Carcinoma: a Prospective, Single-arm Phase 2 Study

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2024-11-01

Completion Date

2027-10-31

Last Updated

2025-01-10

Healthy Volunteers

No

Interventions

DRUG

Irinotecan liposome

Irinotecan liposome injection, 50mg/m2, D1、D15, ivgtt, Q4w.

DRUG

S-1

S-1, D1-D14, BID, p.o., Q4w (BSA \< 1.25 m2, 40 mg/dose; 1.25 m2 ⩽ BSA \< 1.5 m2, 50 mg/dose; BSA ⩾ 1.5 m2, 60mg/dose).

Locations (1)

Fifth affiliated hosptial of Sun-yat Sen university

Zhuhai, Guangzhou, China