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Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC. | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC.

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

NCT06059261•Chongqing University Cancer Hospital

View on ClinicalTrials.gov

Summary

This is a single-center, prospective, single-arm, phase II clinical study, to evaluate the therapeutic efficacy and safety of envafolimab combined with chemoradiotherapy and recombinant human endostatin in patients with locally advanced nasopharyngeal carcinoma.

Detailed Description

This is a single-center, prospective, single-arm phase II clinical study. Patients with high-risk locally advanced stage III-IVA (8th AJCC/UICC staging) primary nasopharyngeal carcinoma, 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.) are enrolled. After being screened to meet the enrolment criteria and signing the informed consent form, they will receive 3 cycles of induction therapy with envafolimab combined with recombinant human vascular endothelial inhibitor and gemcitabine and cisplatin, followed by cisplatin-concomitant radiotherapy, and 8 cycles of adjuvant therapy with envafolimab after radiotherapy.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.
+10 more criteria

Locations (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Key Dates

Start Date

February 9, 2026

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2027

Last Updated

February 18, 2026

Enrollment

ESTIMATED participants

Conditions

Nasopharyngeal Carcinoma

Interventions

Envafolimab and recombinant human endostatin combined with chemoradiotherapy

DRUG

Contacts

Xin Zhang, Ph.D, M.D.

CONTACT

18323063006 zhangxin9964@126.com

Jiang D Sui, Ph.D, M.D.

CONTACT

13594190011 jiangdong.sui@cqu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC.

Inclusion Criteria

Exclusion Criteria

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

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