Actively Recruiting
Penpulimab Plus Gemcitabine and Anlotinib for Metastatic Nasopharyngeal Carcinoma Treatment: A Single-Arm, Open-Label Phase Ib Clinical Trial
Led by Chen Xiaozhong ยท Updated on 2025-03-20
47
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a treatment plan combining Penpulimab, Gemcitabine, and Anlotinib for people with metastatic nasopharyngeal carcinoma. The main goal is to measure how long patients can live without the cancer worsening, known as progression-free survival. This is a Phase 1 clinical trial designed to explore these treatments in this patient group. The treatment involves intravenous Penpulimab infusions of 200 mg on the first day of each 3-week cycle. Gemcitabine is given by intravenous infusion at 1000 mg/m2 on the 1st and 8th days of each cycle, for 4 to 6 cycles. Anlotinib capsules are taken orally once daily on an empty stomach for 2 weeks, followed by a 1-week break, repeating every 3 weeks. This combination regimen is being studied in an open-label, single-arm format. Participants will be closely monitored from baseline up to 2 years. Researchers will assess tumor response, overall survival, quality of life, and other health markers such as PD-L1 expression and blood Epstein-Barr virus levels. Regular visits will include physical exams, laboratory tests, and imaging to track treatment effects and safety. Participants are expected to follow the treatment schedule and attend scheduled assessments throughout the study period.
CONDITIONS
Brief 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 (AJCC 8th edition).
- No prior first-line platinum-based chemotherapy for metastatic disease.
- At least one measurable tumor lesion according to RECIST 1.1 criteria.
- Adequate organ function.
- Female participants of childbearing potential must 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.
- Willing and able to comply with visit schedule, treatment plan, laboratory exams, and other study requirements.
You will not qualify if you...
- History of another malignancy within 3 years prior to first dose, except certain cured cancers like basal cell carcinoma or carcinoma in situ.
- Participation in another investigational drug or device study within 4 weeks before dosing.
- Recent palliative local treatment for non-target lesions within 2 weeks before first dose.
- Use of nonspecific immunomodulatory therapy within 2 weeks before first dose.
- Use of Chinese herbal or patent medicine with anti-tumor effects 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 for locally advanced disease.
- Recurrent nasopharyngeal lesions after radiotherapy with secondary radiotherapy received.
- Prior immunotherapy including checkpoint inhibitors or immune cell therapy.
- Previous anti-angiogenic therapy.
- Presence of serious concomitant diseases or other reasons judged unsuitable by the 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)
Duration - 4 to 18 weeks
Participants receive Penplimab intravenously every 3 weeks, Gemcitabine intravenously on the 1st and 8th days of each 3-week cycle for 4 to 6 cycles, and take Anlotinib orally daily for 2 weeks followed by 1 week off in repeated 3-week cycles.
Repeated visits every 3 weeks for treatment cycles
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
X
Xiaozhong Chen, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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