Actively Recruiting
Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.
Led by Sun Yat-sen University · Updated on 2022-08-10
36
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients diagnosed with locally advanced nasopharyngeal carcinoma will be recruited in this study. All the patients will get 3 cycles of GP+ Envafolimab for the induction chemotherapy. After that, the patients will receive concurrent chemoradiotherapy. Radiotherapy will be given by IMRT, under the dose of GTVnx 68-70Gy/30-33f, 5d/w,6-7w, during which, every patient would receive 2 cycles of DDP+Envafolimab as concurrent chemotherapy. Then patients would receive Envafolimab every 3 weeks for maintenance treatment for a year, until disease progression or intolerance of treatment. . We aim to evaluate the three years progression free survival of these patients by the combination of Envafolimab with curative chemoradiotherapy.
CONDITIONS
Official 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...
- ECOG performance status of 0 or 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
- ALT 2 1.5 times upper limit of normal (ULN), AST 2 1.5 ULN, and bilirubin 2 1.5 ULN
- Creatinine less than 1.5 times ULN
You will not qualify if you...
- Recurrent or metastatic nasopharyngeal carcinoma
- Histologically confirmed keratinizing carcinoma (WHO type I) of nasal pharynx
- Prior radiation or chemotherapy treatment
- Pregnant or lactating women, or women of childbearing potential without birth control
- HIV positive
- History of other cancers
- Prior use of immune checkpoint inhibitors (CTLA-4, PD-1, PD-L1, etc.)
- Long-term treatment with immunosuppressive drugs or corticosteroids at immunosuppressive doses
- Immune deficiency diseases or history of organ transplantation
- Recent use of high-dose glucocorticoids within 4 weeks prior to enrollment
- Laboratory test values not meeting standards within 7 days before enrollment
- Significant impairment of heart, liver, lung, kidney, or bone marrow function
- Serious or uncontrolled medical diseases or infections
- Participation in another clinical trial at the same time
- Positive HBsAg and HBV DNA >1 x 10^3 copies/mL
- Positive HCV unless HCV RNA PCR is negative
- Any other treatment contraindications
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
F
Fei Han
CONTACT
X
Xiaohui Wang
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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