Envafolimab, Induction Chemotherapy, Locally Advanced Nasopharyngeal Carcinoma, PD-L1
Conditions
Brief summary
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.
Interventions
DRUGEnvafolimab Plus Chemoradiotherapy
Envafolimab was administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ECOG 0-1 * histologically confirmed non-keratinizing carcinoma (WHO type II or III) of nasal pharynx * stage III-IVa （AJCC/UICC 8th ）, untreated NPC patients * NE≥ 1.5×10E9/L, HGB ≥ 100g/L and PLT ≥100×10E9/L * ALT≤ 1.5 upper limit of normal (ULN), AST≤ 1.5ULN and bilirubin ≤ 1.5ULN * creatinine\<1.5×ULN
Exclusion criteria
* recurrent or metastatic NPC patients * histologically confirmed keratinizing carcinoma (WHO type I) of nasal pharynx * already received radiation or chemotherapy * pregnant or lactating women, or women of childbearing age without birth control * HIV (+) * had other cancers before * used immune checkpoint inhibitor(CTLA-4、PD-1、PD-L1 etc.) before * complications requiring long-term treatment with immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive dose * with immune deficiency diseases, or a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and hypothyroidism; Patients with vitiligo or asthma in childhood who have completely relieved and do not need any intervention after adulthood can be included; Asthma requiring medical intervention with bronchodilators cannot be included) * use of massive dose of glucocorticoids within 4 weeks before enrollment * laboratory test values do not meet relevant standards within 7 days before enrollment * significantly lower functions of heart, liver, lung, kidney and bone marrow * serious or uncontrolled medical diseases or infections * participating other clinical trial in the same time * HBsAg (+) and HBV DNA \>1×10E3 copiers /mL * HCV (+) unless HCV RNA PCR(-) * with any other treatment contraindications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year progression free survival | 3-year | time from the randomization to the first disease progression or death |
Countries
China
Contacts
Primary ContactFei Han
Backup ContactXiaohui Wang
Outcome results
None listed