Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.
Envafolimab Plus Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma, a Prospective, Single Armed Phase II Trial.
Sun Yat-sen University
36 participants
Jun 8, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria17
- 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
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Interventions
Envafolimab was administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy.
Locations(1)
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NCT05397769