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

ConditionRecurrent or Metastatic Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

1. Willing to participate in the study, sign the informed consent form (ICF), and comply with study plan visits, treatment plans, laboratory tests, and other study procedures.

Disqualifiers

1. Severe allergy to Irinotecan liposome (such as systemic rash/erythema hypotension, bronchospasm, angioedema, or anaphylaxis).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

56 Participants
are divided into 1 treatment group
Group A: Irinotecan liposome groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to treatment

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Progression-free survival (PFS)

Progression-Free Survival PFS is defined as the duration from the date of treatment to progression or death

Time frame
Through study completion, an average of 1 year
2

Overall survival (OS)

Overall survival (OS) is defined as the duration from the date of treatment to death or last follow-up, with no restriction on the cause of death.

Time frame
Through study completion, an average of 1 year
3

Incidence of adverse events

NCI-CTCAE 5.0 standard is adopted.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Sponsor institution

Source ClinicalTrials.gov
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