Combining Envafolimab with Chemoradiotherapy for Advanced Nasopharyngeal Cancer
Envafolimab Plus Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma, a Prospective, Single Armed Phase II Trial.
This study is testing if combining a new drug called Envafolimab with standard chemotherapy and radiation can help people with advanced nasopharyngeal cancer live longer without their cancer getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, radiation, Envafolimab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05397769 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are untreated patients with stage III-IVa non-keratinizing nasopharyngeal carcinoma and an ECOG performance status of 0-1.
Not a fit: Patients with recurrent or metastatic nasopharyngeal carcinoma or those who have previously received chemotherapy or radiation will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could improve survival rates for patients with advanced nasopharyngeal carcinoma.
How similar studies have performed: While this approach is innovative, similar studies combining immunotherapy with chemoradiotherapy have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Fei Han
- Email: hanfei@sysucc.org.cn
- Phone: 13822113698
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.