RecruitingPhase 2NCT06657690

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

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


Sponsor

Sun Yat-sen University

Enrollment

56 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — irinotecan liposome and S-1 (an oral chemotherapy) — for people with nasopharyngeal carcinoma (a cancer at the back of the nose) that has returned or spread and no longer responds to immunotherapy drugs called PD-1/L1 inhibitors. **You may be eligible if...** - You are 18 or older with confirmed nasopharyngeal carcinoma - Your cancer returned or spread after receiving at least one immunotherapy-based treatment (anti-PD-1/L1) - Your cancer cannot be cured with surgery or radiation - You have at least one measurable tumor on scans - You are generally well enough to carry out daily activities - Your expected survival is at least 3 months **You may NOT be eligible if...** - Your cancer has not previously been treated with immunotherapy - You have serious organ dysfunction - You have certain active infections or other cancers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIrinotecan liposome

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

DRUGS-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

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NCT06657690


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