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Recruiting NCT05397769

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

Phase II Interventional Locally Advanced Nasopharyngeal Carcinoma Envafolimab Induction Chemotherapy PD-L1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Envafolimab Plus Chemoradiotherapy.
Who it may be relevant to
Registry conditions: Locally Advanced Nasopharyngeal Carcinoma, Envafolimab, Induction Chemotherapy, PD-L1. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 3-year progression free survival [Time frame: 3-year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT05397769 · B2022-203-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗