Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.

Sun Yat-sen University

Status and phase: Enrolling; Phase 2

Conditions: Envafolimab; PD-L1; Induction Chemotherapy; Locally Advanced Nasopharyngeal Carcinoma

Treatments: Drug: Envafolimab Plus Chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05397769

B2022-203-01

Details and patient eligibility

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Envafolimab group

Experimental group

Description:

Envafolimab is a PD-L1 antibody by hypodermic injection. Envafolimab will be administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy.

Treatment:

Drug: Envafolimab Plus Chemoradiotherapy