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

Sponsor
Sun Yat-sen University
Study ID
NCT06657690
Phase
PHASE2
Status
Recruiting
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Conditions

  • Recurrent or Metastatic Nasopharyngeal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan liposome — DRUG
    Irinotecan liposome injection, 50mg/m2, D1、D15, ivgtt, Q4w.
  • S-1 — DRUG
    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).

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Oct 2024
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan liposome group
    Irinotecan liposome injection combined with S-1 every 4 weeks for up to 6 cycles, until intolerable toxicity, subject withdrawal of informed consent, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts