Actively Recruiting
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
Led by Sun Yat-sen University · Updated on 2025-01-10
56
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, single-arm Phase 2 study to assess the effectiveness and safety of combining Irinotecan Liposome injection with S-1 in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have not responded to at least first-line anti-PD-1/L1 therapy. This study focuses on patients whose cancer cannot be treated with local curative methods and aims to provide new options for those who have progressed despite previous immunotherapy or chemotherapy. Participants will receive Irinotecan Liposome injection at 50 mg/m2 on days 1 and 15 via intravenous infusion every 4 weeks, combined with oral S-1 taken twice daily from days 1 to 14 in 4-week cycles. The dosing of S-1 is adjusted based on body surface area. Treatment continues for up to 6 cycles or until disease progression, unacceptable side effects, withdrawal, new cancer treatment, loss of follow-up, or death. Regular visits and imaging scans will monitor treatment effects and safety. During the study, participants will undergo evaluations including imaging tests to measure tumor response according to RECIST 1.1 criteria. Researchers will monitor objective response rate as the primary outcome and also track progression-free survival, overall survival, and adverse events over about one year. Participants will be followed closely throughout treatment and assessed regularly to gather comprehensive data on treatment impact and safety.
CONDITIONS
Brief Title
Irinotecan Liposome Combined with S-1 in PD-1/L1 Inhibitor Refractory Recurrent or Metastatic NPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate in the study, sign informed consent, and comply with study procedures
- Age 18 to 70 years
- Histopathologically confirmed nasopharyngeal carcinoma (differentiated or undifferentiated non-keratinous carcinoma)
- Recurrent or metastatic nasopharyngeal carcinoma that failed at least first-line anti-PD-1/L1 treatment
- Disease not amenable to local curative treatment (surgery or radiotherapy)
- At least one measurable lesion per RECIST 1.1 criteria
- ECOG performance status 0-1 with expected survival of 3 months or more
- Adequate liver, kidney, and blood function according to specified laboratory values
You will not qualify if you...
- Severe allergy to Irinotecan liposome
- Use of CYP3A4 strong inducers or suppressors shortly before treatment
- Estimated survival less than 3 months
- Positive for active hepatitis B or C infection without controlled treatment
- HIV positive
- Active infections requiring systemic treatment within 1 week before treatment
- Recent chemotherapy, targeted therapy, immunotherapy, or investigational drugs within 4 weeks
- Use of Chinese medicine with antitumor activity within 14 days
- Major surgery within 3 months before treatment or planned during study
- Severe embolic events within 6 months prior to screening
- Other malignancies treated within 2 years except certain curable types
- Severe cardiovascular disease within 6 months prior to enrollment
- Pregnant or lactating women
- Serious dysfunction of vital organs or uncontrolled diseases affecting participation
- Any other condition deemed inappropriate for participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 6 cycles, repeated every 4 weeks
Participants receive Irinotecan liposome injection combined with S-1 every 4 weeks for up to 6 cycles, continuing until disease progression, intolerable toxicity, withdrawal, or other reasons.
Visits every 2 weeks for drug administration and assessments
Duration - Up to 1 year after treatment completion
After treatment ends, participants will have regular visits and imaging examinations to evaluate efficacy and safety over approximately 1 year.
Regular visits with imaging assessments as scheduled
Trial Site Locations
Total: 1 location
1
Fifth affiliated hosptial of Sun-yat Sen university
Zhuhai, Guangzhou, China, 519000
Actively Recruiting
Research Team
M
Mingyuan Chen, MD, PhD
R
Rui You, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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