OncoMatch/Clinical Trials/NCT06657690
Irinotecan Liposome Combined with S-1 in PD-1/L1 Inhibitor Refractory Recurrent or Metastatic NPC
Is NCT06657690 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Irinotecan liposome and S-1 for recurrent or metastatic nasopharyngeal carcinoma.
Treatment: Irinotecan liposome · S-1 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: anti-PD-1 therapy — first-line
has failed at least first-line anti-PD-1/L1, whether or not combined with platinum-containing standard regimen (Anti PD-1/L1 exposure at least 6 weeks...)
Cannot have received: chemotherapy
Received chemotherapy, targeted therapy, immunotherapy, or any investigational drug or other antitumor therapy within 4 weeks or 5 half-lives before first administration (whichever is shorter but at least 2 weeks)
Cannot have received: targeted therapy
Received chemotherapy, targeted therapy, immunotherapy, or any investigational drug or other antitumor therapy within 4 weeks or 5 half-lives before first administration (whichever is shorter but at least 2 weeks)
Cannot have received: immunotherapy
Received chemotherapy, targeted therapy, immunotherapy, or any investigational drug or other antitumor therapy within 4 weeks or 5 half-lives before first administration (whichever is shorter but at least 2 weeks)
Cannot have received: investigational drug
Received chemotherapy, targeted therapy, immunotherapy, or any investigational drug or other antitumor therapy within 4 weeks or 5 half-lives before first administration (whichever is shorter but at least 2 weeks)
Cannot have received: Chinese medicine with antitumor activity
Received Chinese medicine with antitumor activity within 14 days before administration
Lab requirements
Blood counts
neutrophil absolute value (ANC) ≥1.0×10^9/L, hemoglobin (Hb) ≥ 9.0 g/dL, platelets ≥ 100×10^9/L
Kidney function
serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 30 mL/min according to Cockcroft-Gault formula
Liver function
AST and ALT ≤ 2.5 times ULN, bilirubin ≤ 1.5 times ULN (patients with known Gilbert disease and serum bilirubin level ≤ 3 times ULN could be enrolled; patients with liver metastasis, ≤ 5 times ULN)
Adequate main organ function: a. Liver function: AST and ALT ≤ 2.5 times ULN, bilirubin ≤ 1.5 times ULN (patients with known Gilbert disease and serum bilirubin level ≤ 3 times ULN could be enrolled; patients with liver metastasis, ≤ 5 times ULN); b. Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 30 mL/min according to Cockcroft-Gault formula; c. Hematology: neutrophil absolute value (ANC) ≥1.0×10^9/L, hemoglobin (Hb) ≥ 9.0 g/dL, platelets ≥ 100×10^9/L.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06657690 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, targeted therapy, immunotherapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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