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

Primary Purpose

Locally Advanced Nasopharyngeal Carcinoma, Envafolimab, Induction Chemotherapy

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Envafolimab Plus Chemoradiotherapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Envafolimab group

Arm 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.

Outcomes

Primary Outcome Measures

3-year progression free survival
time from the randomization to the first disease progression or death

Secondary Outcome Measures

Full Information

First Posted
May 26, 2022
Last Updated
August 9, 2022
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05397769
Brief Title
Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.
Official Title
Envafolimab Plus Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma, a Prospective, Single Armed Phase II Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2022 (Actual)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Nasopharyngeal Carcinoma, Envafolimab, Induction Chemotherapy, PD-L1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Envafolimab group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Envafolimab Plus Chemoradiotherapy
Intervention Description
Envafolimab was administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy.
Primary Outcome Measure Information:
Title
3-year progression free survival
Description
time from the randomization to the first disease progression or death
Time Frame
3-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Han
Phone
13822113698
Ext
86
Email
hanfei@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohui Wang
Phone
18826260661
Ext
86
Email
wangxh@sysucc.org.cn
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Han
Phone
13822113698
Ext
86
Email
hanfei@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Fei Han, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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