Combining Envafolimab with Chemoradiotherapy for Advanced Nasopharyngeal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial focuses on patients with locally advanced nasopharyngeal carcinoma who will receive a combination of Envafolimab and chemoradiotherapy. Participants will undergo three cycles of induction chemotherapy with GP and Envafolimab, followed by concurrent chemoradiotherapy using intensity-modulated radiation therapy (IMRT). The study aims to evaluate the three-year progression-free survival rate of patients receiving this treatment regimen. The trial is designed as a single-arm Phase II study, meaning all participants will receive the same treatment without a control group.

Why it matters

Who can join: the full rules

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

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Fei Han
• Email: hanfei@sysucc.org.cn
• Phone: 13822113698

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• KGX101 alone and with envafolimab for advanced or metastatic solid tumors

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.