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.

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.

Study Overview

• Status: Recruiting
• Conditions: Induction Chemotherapy; Locally Advanced Nasopharyngeal Carcinoma; PD-L1; Envafolimab
• Intervention / Treatment: Drug: Envafolimab Plus Chemoradiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fei Han; Phone Number: 86 13822113698; Email: hanfei@sysucc.org.cn
• Study Contact Backup: Name: Xiaohui Wang; Phone Number: 86 18826260661; Email: wangxh@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Fei Han; Phone Number: 86 13822113698; Email: hanfei@sysucc.org.cn
      • Principal Investigator: Fei Han, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Envafolimab group; 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.	Drug: Envafolimab 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year progression free survival	time from the randomization to the first disease progression or death	3-year

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Anticipated): June 1, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: B2022-203-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No