Induction Chemotherapy Clinical Trial
Official title:
Envafolimab Plus Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma, a Prospective, Single Armed Phase II Trial.
Verified date | August 2022 |
Source | Sun Yat-sen University |
Contact | Fei Han |
Phone | 13822113698 |
hanfei[@]sysucc.org.cn | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | December 31, 2026 |
Est. primary completion date | June 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3-year progression free survival | time from the randomization to the first disease progression or death | 3-year |
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