Combining envafolimab with chemoradiotherapy for advanced nasopharyngeal carcinoma

A Prospective, Single-arm, Phase II Study of Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin in Locally Advanced Nasopharyngeal Carcinoma.

This study is testing if adding a new drug called envafolimab to standard chemotherapy and radiation can help people with advanced nasopharyngeal cancer do better in their treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Chongqing University Cancer Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy, envafolimab
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT06059261 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, single-arm phase II clinical study aims to evaluate the efficacy and safety of envafolimab in combination with chemoradiotherapy and recombinant human endostatin for patients with high-risk locally advanced nasopharyngeal carcinoma. Eligible patients will receive three cycles of induction therapy followed by cisplatin-concomitant radiotherapy and eight cycles of adjuvant therapy with envafolimab. The study focuses on patients with specific staging criteria and requires various pre-treatment assessments, including tumor tissue collection for testing. The goal is to improve treatment outcomes for this challenging cancer type.

Who should consider this trial

Good fit: Ideal candidates are treatment-naive patients aged 18-65 with high-risk locally advanced nasopharyngeal carcinoma.

Not a fit: Patients with early-stage nasopharyngeal carcinoma or those who have received prior treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance treatment efficacy and safety for patients with advanced nasopharyngeal carcinoma.

How similar studies have performed: While similar approaches have been explored, this specific combination of therapies in this patient population is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. ECOG score 0-1.
2. Aged 18-65 years, male or non-pregnant female;
3. Pathologically confirmed diagnosis of nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, WHO type II or III) without the need to detect MSI and dMMR status.
4. high-risk locally advanced stage III-IVA (8th AJCC/UICC staging), i.e., T4N+ or N2-3, or pretreatment EBV-DNA ≥4000 copies/ml, or lymph node extra-envelope invasion grade 3 (invasion of muscle skin, etc.), treatment-naive nasopharyngeal carcinoma patients.
5. MRI data of nasopharynx and neck before enrollment, and measurable lesions;
6. Agree to provide a previously stored tumor tissue specimen or biopsy to collect tumor lesion tissue and send it to the central laboratory for PD-L1 IHC testing.
7. Agree to undergo EBV antibody and EBV-DNA quantitative testing before receiving treatment.
8. Hematology: WBC ≥ 4000/μL, neutrophils ≥ 2.000/μL, hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL;
9. Liver function: ALT, AST \< 1.5 times the upper limit of normal (ULN), total bilirubin \< 1.5 × ULN;
10. Renal function: serum creatinine \< 1.5 × ULN.
11. Patients have signed the informed consent form and are willing and able to comply with the study plan visits, treatment plan, laboratory tests and other study procedures;

Exclusion Criteria:

1. Patients with recurrent nasopharyngeal carcinoma and distant metastasis.
2. Pathology was keratinizing squamous cell carcinoma (WHO classification type I).
3. Patients who have undergone radiotherapy or systemic chemotherapy;
4. Pregnant or lactating women, in the reproductive period without effective contraceptive measures;
5. HIV positive.
6. Having had other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ);
7. Patients who have been treated with inhibitors of immune regulatory points (CTLA-4, PD-1, PD-L1, etc.);
8. Patients need long-term use of immunosuppressive drug therapy, or systemic or local use of immunosuppressive doses of corticosteroids complications;
9. Patients with immunodeficiency disease, history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or complete remission of asthma in childhood, without any intervention after adulthood can be included; patients with asthma requiring bronchodilators for medical intervention can not be included;
10. Use of excessive doses of glucocorticoids within 4 weeks.
11. Laboratory test values within 7 days before enrollment do not meet the relevant criteria;
12. Patients with significantly low heart, liver, lung, kidney and bone marrow function.
13. Any other diseases or conditions are contraindications to recombinant human vascular endothelial inhibitors, chemoradiotherapy, immunotherapy (such as active phase of infection, within 6 months after myocardial infarction, symptomatic heart disease including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);
14. Any arterial thrombosis, embolism or ischemia within 6 months before inclusion for treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack;
15. Severe, uncontrolled medical illness and infection.
16. Concurrent use of other investigational drugs or ongoing other clinical trials;
17. Refusing or unable to sign the informed consent form to participate in the trial.
18. Personality or mental disorders, no civil capacity or limited civil capacity;
19. Hepatitis B surface antigen (HBsAg) positive and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 1000cps/ml.
20. Patients who tested positive for HCV antibody were included in the study only if they tested negative for HCV RNA by polymerase chain reaction.

Where this trial is running

Chongqing, Chongqing Municipality

• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Jiang D Sui, Ph.D, M.D. — Chongqing University Cancer Hospital
• Study coordinator: Xin Zhang, Ph.D, M.D.

Conditions: Nasopharyngeal Carcinoma