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

NCT06059261 | Recruiting Phase 2

• 1 other identifier: Lance
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate (CRR) after Induction Therapy

  The proportion of patients in whom all target and non-target lesions confirmed at baseline have completely disappeared, as assessed by magnetic resonance imaging (MRI) following the completion of induction therapy.

  From enrollment to the end of induction therapy at 12 weeks

Secondary Outcomes (6)

• Objective Response Rate (ORR) after Induction Therapy

  From enrollment to the end of induction therapy at 12 weeks

• Progression Free Survival (PFS)

  2 years

• Overall survival (OS)

  2 years

• Locoregional Relapse-Free Survival (LRRFS)

  2 years

• Distant metastases-Free survival (DMFS)

  2 years

Study Arms (1)

Envafolimab and recombinant human endostatin combined with chemoradiotherapy

EXPERIMENTAL

Intervention Description: Induction envafolimab combined with recombinant endostatin and gemcitabine and cisplatin therapy for three cycles (every 3 weeks) followed by definitive radiotherapy with concurrent cisplatin chemotherapy. After 4 weeks of the completion of radiotherapy, adjuvant envafolimab therapy will begin every 3 weeks for 8 cycles or continue until progression or unacceptable toxicity.

Drug: Envafolimab and recombinant human endostatin combined with chemoradiotherapy

Interventions

Envafolimab and recombinant human endostatin combined with chemoradiotherapy DRUG

Induction treatment phase: Envafolimab administered by subcutaneous injection on day 1 every 3 weeks at 300 mg for 3 cycles, cisplatin administered by intravenous infusion on day 1 of each cycle at 80 mg/m2 every 3 weeks for 3 cycles, gemcitabine was administered by intravenous infusion on days 1 and 8 of each cycle at 1 g/m2 every 3 weeks for 3 cycles, recombinant human endostatin was administered on day 1 every 3 weeks at 210 mg for 3 cycles. Concurrent treatment phase: Cisplatin was administered by intravenous infusion on day 1 of each cycle at 100mg/m2 every 3 weeks for 2 cycles. Adjuvant treatment Phase: Envafolimab was administered on day 1 every 3 weeks at 300 mg for 8 cycles as a subcutaneous injection. Intensity-modulated radiotherapy: 69.96Gy/33fractions/7 weeks,5 fractions/week, 1 fraction/day.

Envafolimab and recombinant human endostatin combined with chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG score 0-1.
• Aged 18-65 years, male or non-pregnant female;
• 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.
• 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.
• MRI data of nasopharynx and neck before enrollment, and measurable lesions;
• 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.
• Agree to undergo EBV antibody and EBV-DNA quantitative testing before receiving treatment.
• Hematology: WBC ≥ 4000/μL, neutrophils ≥ 2.000/μL, hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL;
• Liver function: ALT, AST \< 1.5 times the upper limit of normal (ULN), total bilirubin \< 1.5 × ULN;
• Renal function: serum creatinine \< 1.5 × ULN.
• 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;

You may not qualify if:

• Patients with recurrent nasopharyngeal carcinoma and distant metastasis.
• Pathology was keratinizing squamous cell carcinoma (WHO classification type I).
• Patients who have undergone radiotherapy or systemic chemotherapy;
• Pregnant or lactating women, in the reproductive period without effective contraceptive measures;
• HIV positive.
• Having had other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ);
• Patients who have been treated with inhibitors of immune regulatory points (CTLA-4, PD-1, PD-L1, etc.);
• Patients need long-term use of immunosuppressive drug therapy, or systemic or local use of immunosuppressive doses of corticosteroids complications;
• 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;
• Use of excessive doses of glucocorticoids within 4 weeks.
• Laboratory test values within 7 days before enrollment do not meet the relevant criteria;
• Patients with significantly low heart, liver, lung, kidney and bone marrow function.
• 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);
• Severe, uncontrolled medical illness and infection.
• Concurrent use of other investigational drugs or ongoing other clinical trials;

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead

Study Sites (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Related Publications (15)

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

• Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. Lancet. 2019 Jul 6;394(10192):64-80. doi: 10.1016/S0140-6736(19)30956-0. Epub 2019 Jun 6.

  PMID: 31178151 BACKGROUND

• Zhang L, Huang Y, Hong S, Yang Y, Yu G, Jia J, Peng P, Wu X, Lin Q, Xi X, Peng J, Xu M, Chen D, Lu X, Wang R, Cao X, Chen X, Lin Z, Xiong J, Lin Q, Xie C, Li Z, Pan J, Li J, Wu S, Lian Y, Yang Q, Zhao C. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. Lancet. 2016 Oct 15;388(10054):1883-1892. doi: 10.1016/S0140-6736(16)31388-5. Epub 2016 Aug 23.

  PMID: 27567279 BACKGROUND

• Mao YP, Xie FY, Liu LZ, Sun Y, Li L, Tang LL, Liao XB, Xu HY, Chen L, Lai SZ, Lin AH, Liu MZ, Ma J. Re-evaluation of 6th edition of AJCC staging system for nasopharyngeal carcinoma and proposed improvement based on magnetic resonance imaging. Int J Radiat Oncol Biol Phys. 2009 Apr 1;73(5):1326-34. doi: 10.1016/j.ijrobp.2008.07.062. Epub 2009 Jan 17.

  PMID: 19153016 BACKGROUND

• Li XY, Chen QY, Sun XS, Liu SL, Yan JJ, Guo SS, Liu LT, Xie HJ, Tang QN, Liang YJ, Wen YF, Guo L, Mo HY, Chen MY, Sun Y, Ma J, Tang LQ, Mai HQ. Ten-year outcomes of survival and toxicity for a phase III randomised trial of concurrent chemoradiotherapy versus radiotherapy alone in stage II nasopharyngeal carcinoma. Eur J Cancer. 2019 Mar;110:24-31. doi: 10.1016/j.ejca.2018.10.020. Epub 2019 Feb 7.

  PMID: 30739837 BACKGROUND

• Au KH, Ngan RKC, Ng AWY, Poon DMC, Ng WT, Yuen KT, Lee VHF, Tung SY, Chan ATC, Sze HCK, Cheng ACK, Lee AWM, Kwong DLW, Tam AHP. Treatment outcomes of nasopharyngeal carcinoma in modern era after intensity modulated radiotherapy (IMRT) in Hong Kong: A report of 3328 patients (HKNPCSG 1301 study). Oral Oncol. 2018 Feb;77:16-21. doi: 10.1016/j.oraloncology.2017.12.004. Epub 2017 Dec 12.

  PMID: 29362121 BACKGROUND

• Sun X, Su S, Chen C, Han F, Zhao C, Xiao W, Deng X, Huang S, Lin C, Lu T. Long-term outcomes of intensity-modulated radiotherapy for 868 patients with nasopharyngeal carcinoma: an analysis of survival and treatment toxicities. Radiother Oncol. 2014 Mar;110(3):398-403. doi: 10.1016/j.radonc.2013.10.020. Epub 2013 Nov 11.

  PMID: 24231245 BACKGROUND

• Chen L, Hu CS, Chen XZ, Hu GQ, Cheng ZB, Sun Y, Li WX, Chen YY, Xie FY, Liang SB, Chen Y, Xu TT, Li B, Long GX, Wang SY, Zheng BM, Guo Y, Sun Y, Mao YP, Tang LL, Chen YM, Liu MZ, Ma J. Adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicentre randomised controlled trial. Eur J Cancer. 2017 Apr;75:150-158. doi: 10.1016/j.ejca.2017.01.002. Epub 2017 Feb 22.

  PMID: 28235726 BACKGROUND

• Chen L, Hu CS, Chen XZ, Hu GQ, Cheng ZB, Sun Y, Li WX, Chen YY, Xie FY, Liang SB, Chen Y, Xu TT, Li B, Long GX, Wang SY, Zheng BM, Guo Y, Sun Y, Mao YP, Tang LL, Chen YM, Liu MZ, Ma J. Concurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial. Lancet Oncol. 2012 Feb;13(2):163-71. doi: 10.1016/S1470-2045(11)70320-5. Epub 2011 Dec 7.

  PMID: 22154591 BACKGROUND

• Peng H, Chen L, Zhang J, Li WF, Mao YP, Zhang Y, Liu LZ, Tian L, Lin AH, Sun Y, Ma J. Induction Chemotherapy Improved Long-term Outcomes of Patients with Locoregionally Advanced Nasopharyngeal Carcinoma: A Propensity Matched Analysis of 5-year Survival Outcomes in the Era of Intensity-modulated Radiotherapy. J Cancer. 2017 Feb 10;8(3):371-377. doi: 10.7150/jca.16732. eCollection 2017.

  PMID: 28261337 BACKGROUND

• Hui EP, Ma BB, Leung SF, King AD, Mo F, Kam MK, Yu BK, Chiu SK, Kwan WH, Ho R, Chan I, Ahuja AT, Zee BC, Chan AT. Randomized phase II trial of concurrent cisplatin-radiotherapy with or without neoadjuvant docetaxel and cisplatin in advanced nasopharyngeal carcinoma. J Clin Oncol. 2009 Jan 10;27(2):242-9. doi: 10.1200/JCO.2008.18.1545. Epub 2008 Dec 8.

  PMID: 19064973 BACKGROUND

• Zhang Y, Chen L, Hu GQ, Zhang N, Zhu XD, Yang KY, Jin F, Shi M, Chen YP, Hu WH, Cheng ZB, Wang SY, Tian Y, Wang XC, Sun Y, Li JG, Li WF, Li YH, Tang LL, Mao YP, Zhou GQ, Sun R, Liu X, Guo R, Long GX, Liang SQ, Li L, Huang J, Long JH, Zang J, Liu QD, Zou L, Su QF, Zheng BM, Xiao Y, Guo Y, Han F, Mo HY, Lv JW, Du XJ, Xu C, Liu N, Li YQ, Chua MLK, Xie FY, Sun Y, Ma J. Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma. N Engl J Med. 2019 Sep 19;381(12):1124-1135. doi: 10.1056/NEJMoa1905287. Epub 2019 May 31.

  PMID: 31150573 BACKGROUND

• Jiang XD, Dai P, Wu J, Song DA, Yu JM. Inhibitory effect of radiotherapy combined with weekly recombinant human endostatin on the human pulmonary adenocarcinoma A549 xenografts in nude mice. Lung Cancer. 2011 May;72(2):165-71. doi: 10.1016/j.lungcan.2010.09.003. Epub 2010 Oct 20.

  PMID: 20965604 BACKGROUND

• Jain RK. Normalization of tumor vasculature: an emerging concept in antiangiogenic therapy. Science. 2005 Jan 7;307(5706):58-62. doi: 10.1126/science.1104819.

  PMID: 15637262 BACKGROUND

• Guan Y, Li A, Xiao W, Liu S, Chen B, Lu T, Zhao C, Han F. The efficacy and safety of Endostar combined with chemoradiotherapy for patients with advanced, locally recurrent nasopharyngeal carcinoma. Oncotarget. 2015 Oct 20;6(32):33926-34. doi: 10.18632/oncotarget.5271.

  PMID: 26418895 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

envafolimab; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Jiang D Sui, Ph.D, M.D.

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Chongqing University Cancer Hospital

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: September 28, 2023
• Study Start: February 9, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)