Actively Recruiting
Sintilimab Combined With Anlotinib and Taxane-Based Chemotherap for Recurrent/Metastatic Nasopharyngeal Carcinoma
Led by Ming-Yuan Chen · Updated on 2026-05-12
33
Participants Needed
1
Research Sites
171 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 sintilimab combined with anlotinib and taxane-based chemotherapy in patients with recurrent (not unable to locally curative treatment) or metastatic NPC who failed at least first-line platinum-containing standard regimen and/or anti PD-1/L1.
CONDITIONS
Official Title
Sintilimab Combined With Anlotinib and Taxane-Based Chemotherap for Recurrent/Metastatic Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any trial procedures
- Age between 18 and 65 years
- Histological or cytological diagnosis of nasopharyngeal nonkeratinizing carcinoma (WHO type II or III)
- Recurrent or metastatic nasopharyngeal carcinoma after failure of first-line platinum-containing and/or second-line standard treatments
- At least one measurable lesion according to RECIST v1.1
- Asymptomatic or stable brain metastases meeting specified criteria
- Completed palliative radiotherapy at least 1 week before enrollment with toxicity recovered to grade 1 or less (except hair loss)
- ECOG performance status 0-1
- Life expectancy greater than 3 months
- Use of effective contraception during treatment and for 120 days after last study drug (or 180 days as specified)
You will not qualify if you...
- Diagnosis of another malignancy within 5 years prior to first dose (excluding certain cured skin cancers)
- Participation in another interventional clinical study or use of investigational drugs/devices within 4 weeks prior to first dose
- Systemic treatment with traditional Chinese medicine or immunomodulatory drugs for anti-tumor purposes within 2 weeks prior to first dose
- Active autoimmune diseases requiring systemic therapy within 2 years prior to first treatment
- Use of systemic glucocorticoids or immunosuppressive therapy within 7 days prior to first study administration
- Clinically uncontrolled pleural or abdominal effusion
- History of allogeneic organ or hematopoietic stem cell transplantation (except corneal)
- Known allergy to sintilimab or anlotinib hydrochloride
- Conditions affecting oral medication intake
- Severe liver or kidney dysfunction
- Unrecovered toxicity or complications from prior interventions
- HIV infection
- Untreated active hepatitis B or active HCV infection
- Live vaccine within 30 days prior to first dose (except seasonal influenza injection)
- Pregnancy or lactation
- Severe or uncontrolled systemic diseases including serious heart conditions, uncontrolled blood pressure, active infections, significant liver disorders, poorly controlled diabetes, or psychiatric disorders
- Any condition or laboratory abnormality that may interfere with study participation or results as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fifth Affiliated Hospital of Sun Yat-sen University Zhuhai, Guangdong, China, 519000
Zhuhai, Guangdong, China
Actively Recruiting
Research Team
M
Ming-Yuan Chen, MD, PhD
CONTACT
J
Jijin Yao, MD
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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