Actively Recruiting
A Prospective, Single-Arm Phase II Trial of Sintilimab Combined With Anlotinib and Taxane-Based Chemotherapy in Previously Immunotherapy-Treated Recurrent/Metastatic Nasopharyngeal Carcinoma
Led by Ming-Yuan Chen · Updated on 2026-05-12
33
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination treatment involving sintilimab, anlotinib, and taxane-based chemotherapy for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have not been cured by local treatments and have failed previous first-line platinum chemotherapy or immunotherapy. This Phase 2 study focuses on patients with this condition who need new treatment options. The trial is designed to assess how well this triple combination works and how safe it is for participants. The treatment regimen includes sintilimab given intravenously at 200mg on day 1 every three weeks, anlotinib taken orally at 12mg daily from day 1 to day 14 every three weeks, and a taxane chemotherapy drug selected from docetaxel, paclitaxel, or nab-paclitaxel administered intravenously once every three weeks for up to six cycles. After chemotherapy, patients continue receiving sintilimab and anlotinib every three weeks for up to two years or until disease progression or other study endpoints occur. Participants will attend regular visits where the research team will conduct imaging exams and other assessments to monitor treatment response and safety. The primary outcome is the objective response rate measured over an average of two years, with additional evaluations including disease control, duration of response, progression-free survival, and overall survival. The study continues until disease progression, intolerable side effects, withdrawal, new therapy initiation, loss of follow-up, death, or study completion.
CONDITIONS
Brief 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-related procedures
- Age between 18 and 65 years
- Histological or cytological confirmation 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 regimens
- At least one measurable lesion according to RECIST v1.1 criteria
- Participants with asymptomatic or stable brain metastases meeting specific criteria
- Completion of any palliative radiotherapy at least 1 week prior and recovery from toxicity to grade 1 or less
- ECOG performance status of 0 to 1
- Life expectancy greater than 3 months
- Use of effective contraception during treatment and for 120 days after last study drug administration if pregnancy risk exists
You will not qualify if you...
- Diagnosis of other malignancies within 5 years before first dose, except certain skin cancers
- Current participation in other interventional clinical studies or recent investigational drug/device use within 4 weeks
- Recent systemic treatment with traditional Chinese medicine or immunomodulatory drugs within 2 weeks
- Active autoimmune diseases requiring systemic therapy within 2 years
- Use of systemic glucocorticoids or immunosuppressive therapy within 7 days before first dose
- Clinically uncontrolled pleural or abdominal effusion
- History of allogeneic organ or hematopoietic stem cell transplantation
- Known allergy to sintilimab, anlotinib, or study drug components
- Conditions affecting oral medication intake
- Severe coughing, liver or kidney dysfunction
- Unrecovered toxicity from prior treatments above grade 1 except fatigue or hair loss
- HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- Live vaccinations within 30 days before first dose (except certain influenza vaccines)
- Pregnancy or lactation
- Severe or uncontrolled systemic diseases including significant heart, lung, liver, or metabolic conditions
- Psychiatric disorders affecting treatment compliance
- Other conditions or risks deemed unsuitable by 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.
Duration - Up to 2 years or until disease progression or intolerable toxicity
Participants receive sintilimab combined with anlotinib and taxane-based chemotherapy once every 3 weeks for up to 6 cycles, followed by sintilimab and anlotinib every 3 weeks for up to 2 years or until disease progression or intolerable toxicity.
Visits every 3 weeks during treatment cycles and maintenance
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
J
Jijin Yao, MD
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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