Actively Recruiting
Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic NPC After First-line Treatment Failure: A Single-arm Phase IIa Clinical Trial
Led by Sun Yat-sen University · Updated on 2026-01-23
41
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to preliminarily explore the efficacy and safety of Iparomlimab and Tuvonralimab in combination with Nimotuzumab for the treatment of recurrent/metastatic nasopharyngeal carcinoma (NPC). It is expected to investigate a novel therapeutic regimen with improved efficacy and enhanced safety for recurrent/metastatic NPC, thereby providing robust evidence-based medical support for the application of dual-target immune checkpoint inhibitors in nasopharyngeal carcinoma therapy
CONDITIONS
Official Title
Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic NPC After First-line Treatment Failure: A Single-arm Phase IIa Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status score of 0-1
- Age between 18 and 70 years
- Histologically confirmed nasopharyngeal carcinoma
- Locoregional recurrence unsuitable for surgery or radiotherapy, or distant metastasis after standard treatment, or initially metastatic NPC with first-line cisplatin-based treatment failure
- Nasopharyngeal and neck MRI available prior to enrollment with at least one measurable lesion (excluding bone metastases)
- Willing to provide archived tumor tissue or undergo biopsy for PD-L1 testing
- Laboratory tests within 7 days before enrollment meeting specified hematology, liver, and renal function criteria
- Voluntary participation with signed informed consent form
You will not qualify if you...
- History of other malignancies except adequately treated non-melanoma skin cancer, in situ carcinoma, or cancers cured more than 5 years prior
- Need for long-term immunosuppressive therapy or systemic/local corticosteroids at immunocompromising doses
- Immunodeficiency diseases or history of organ transplantation including interstitial pneumonia, hepatitis, nephritis, hyperthyroidism, hypothyroidism
- Positive for HIV, active hepatitis B or C infection
- Use of high-dose glucocorticoids within 4 weeks prior to enrollment
- Pregnant or lactating women, or individuals of reproductive potential without effective contraception
- Laboratory abnormalities outside protocol-specified limits within 7 days before enrollment
- Significant impairment of heart, liver, lung, kidney, or bone marrow function
- Uncontrolled comorbidities or active infections
- Participation in other clinical trials or use of investigational drugs
- Inability or unwillingness to provide informed consent
- Other contraindications to study treatment
- Psychiatric or cognitive conditions limiting legal competency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangdong, China
Actively Recruiting
Research Team
H
hui xiao wang, Ph.D. (Doctor of Philosophy)
CONTACT
F
fei han, Ph.D. (Doctor of Philosophy)
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