Actively Recruiting
Irinotecan Liposome Combined with S-1 in PD-1/L1 Inhibitor Refractory Recurrent or Metastatic NPC
Led by Sun Yat-sen University · Updated on 2025-01-10
56
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 and sign informed consent
- Age 18 to 70 years
- Histopathologically confirmed nasopharyngeal carcinoma (differentiated or undifferentiated non-keratinous)
- Recurrent or metastatic NPC that failed at least first-line anti-PD-1/L1 therapy
- Disease not suitable for 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 functions as specified
You will not qualify if you...
- Severe allergy to Irinotecan liposome
- Use of CYP3A4 strong inducer within 2 weeks or CYP3A4/UGT1A1 strong suppressor within 1 week prior to treatment
- Estimated survival less than 3 months
- Positive for HBsAg and high HBV DNA or chronic hepatitis C infection without control
- HIV positive
- Active infection requiring systemic treatment within 1 week prior to treatment
- Received chemotherapy, targeted therapy, immunotherapy, or investigational drugs within 4 weeks or 5 half-lives before treatment
- Used Chinese medicine with antitumor activity within 14 days before treatment
- Major surgery within 3 months before treatment or planned during study
- Severe embolic events in past 6 months
- Other malignancies diagnosed or treated within 2 years except certain curable cancers
- Severe cardiovascular disease within 6 months before enrollment
- Pregnant or breastfeeding women
- Serious dysfunction of vital organs or uncontrolled serious diseases
- Other investigator-determined reasons inappropriate for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
R
Rui You, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here