Actively Recruiting
Envafolimab Plus Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma, a Prospective, Single Armed Phase II Trial.
Led by Sun Yat-sen University · Updated on 2022-08-10
36
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Envafolimab with chemoradiotherapy for patients diagnosed with locally advanced nasopharyngeal carcinoma. This prospective, single-arm phase II trial aims to assess the three-year progression-free survival of these patients. Envafolimab is a PD-L1 antibody administered by hypodermic injection, studied here alongside curative chemoradiotherapy to better understand its potential impact on this condition. Participants will first receive three cycles of induction chemotherapy combining GP (gemcitabine plus cisplatin) with Envafolimab. Following this, they will undergo concurrent chemoradiotherapy using intensity-modulated radiotherapy (IMRT) delivering a dose of 68-70 Gy over 30-33 fractions, five days a week for six to seven weeks. During radiotherapy, patients receive two cycles of cisplatin and Envafolimab concurrently. Afterwards, they continue receiving Envafolimab every three weeks for maintenance treatment for up to one year or until disease progression or intolerance. During the study, participants will be closely monitored with regular assessments to track disease progression and treatment tolerance. The main outcome measured is the three-year progression-free survival, reflecting the length of time patients remain free from disease progression. The entire course of treatment and follow-up will span up to one year of maintenance therapy, with ongoing safety and response evaluations throughout the trial period.
CONDITIONS
Brief Title
Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- ECOG performance status of 0 to 1
- Histologically confirmed non-keratinizing carcinoma (WHO type II or III) of the nasal pharynx
- Stage III to IVa nasopharyngeal carcinoma, untreated
- Neutrophil count 2 1.5 x 10^9/L, hemoglobin 2 100 g/L, and platelet count 2 100 x 10^9/L
- Liver enzymes ALT and AST 2 1.5 times upper limit of normal, bilirubin 2 1.5 times upper limit of normal
- Creatinine less than 1.5 times upper limit of normal
You will not qualify if you...
- Recurrent or metastatic nasopharyngeal carcinoma
- Histologically confirmed keratinizing carcinoma (WHO type I) of the nasal pharynx
- Prior radiation or chemotherapy treatment
- Pregnant or lactating women, or women of childbearing potential without birth control
- HIV positive status
- Previous other cancers
- Prior use of immune checkpoint inhibitors such as CTLA-4, PD-1, or PD-L1 inhibitors
- Long-term immunosuppressive treatment or corticosteroids at immunosuppressive doses
- Immune deficiency diseases or history of organ transplantation
- Recent use of high-dose glucocorticoids within 4 weeks before enrollment
- Laboratory test values outside required standards within 7 days before enrollment
- Significant dysfunction of heart, liver, lung, kidney, or bone marrow
- Serious or uncontrolled medical diseases or infections
- Concurrent participation in another clinical trial
- Positive hepatitis B surface antigen with high viral load
- Positive hepatitis C unless viral RNA is negative
- Any other treatment contraindications
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 - Approximately 66 weeks (22 cycles every 3 weeks)
Participants receive Envafolimab combined with chemoradiotherapy. Envafolimab is administered as a 300 mg injection every three weeks for a total of 22 cycles starting from the first day of induction chemotherapy.
Visits every 3 weeks for drug administration
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
F
Fei Han
X
Xiaohui Wang
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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