Actively Recruiting
Metastatic Nasopharyngeal Carcinoma
Led by Chen Xiaozhong · Updated on 2025-03-20
47
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluaate the efficacy and safety of the regimen incuding Penpulimab, Gemcitabine and Anlotinib in the treatment of metastatic nasopharyngeal carcinoma. Using Progression-Free-Survival as the primary endpoint.
CONDITIONS
Official Title
Metastatic Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily sign an informed consent form.
- Age between 18 and 75 years at enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival of at least 3 months.
- Histologically or cytologically confirmed stage IVb nasopharyngeal carcinoma.
- No prior first-line platinum-based chemotherapy for metastatic disease.
- At least one measurable tumor lesion as defined by RECIST 1.1.
- Adequate organ function.
- Female participants of childbearing potential must agree to use contraception during the study and for 6 months after; must have a negative pregnancy test within 7 days before entry and not be breastfeeding.
- Male participants must agree to use contraception during the study and for 6 months after.
- Willingness and ability to comply with study visits, treatment plan, and laboratory exams.
You will not qualify if you...
- History of another malignancy within 3 years except nasopharyngeal carcinoma or certain cured cancers.
- Participation in investigational drug or device treatment within 4 weeks before first dose.
- Recent palliative local treatment within 2 weeks before first dose.
- Recent nonspecific immunomodulatory therapy within 2 weeks before first dose.
- Use of Chinese herbal or patent medicines with anti-tumor indications within 1 week before first dose.
- Disease progression during or within 6 months after systemic treatment for locally advanced disease.
- Local recurrence and distant metastasis after radical treatment.
- Recurrent nasopharyngeal lesions after radiotherapy with secondary radiotherapy received.
- Prior immunotherapy including immune checkpoint inhibitors or immune cell therapy.
- Prior anti-angiogenic therapy.
- Serious concomitant diseases endangering safety or study completion as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
X
Xiaozhong Chen, Doctor
CONTACT
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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