Concurrent Chemoradiotherapy with Nimotuzumab for High Risk Nasopharyngeal Carcinoma

Last updated: February 28, 2025
Sponsor: Sun Yat-sen University
Overall Status: Active - Not Recruiting

Phase

2

Condition

Nasopharyngeal Cancer

Carcinoma

Treatment

CCRT+Nimotuzumab

CCRT alone

Clinical Study ID

NCT04223024
B2019-191
  • Ages 18-70
  • All Genders

Study Summary

This is the first phase II randomized clinical trial of concurrent chemoradiotherapy with or without EGFR blocker Nimotuzumab for high risk advanced nasopharyngeal carcinoma(NPC) , determining whether concurrent chemoradiotherapy(CCRT) combined with nimotuzumab can improve the survival rate of high-risk patients and may provide new evidence for individualized comprehensive treatment of locally advanced NPC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-70, regardless of sex.

  2. Patients with newly histologically confirmed non-keratinizing nasopharyngealcarcinoma with positive EGFR expression, type of WHO II or III, clinical stageII-IVa (according to the 8th American Joint Committee on Cancer[AJCC] edition)

  3. Patients with plasma EBV DNA> 0 copy/mL or SD/PD according to RECIST after two cycleinduction chemotherapy

  4. ECOG (Eastern Cooperative Oncology Group) score: 0-1

  5. Women in their reproductive years should ensure that they use contraception duringthe study period.

  6. Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.

  7. Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)< 2.5times the upper limit of normal value (ULN), total bilirubin <2.0×ULN.

  8. Renal function: serum creatinine <1.5×ULN

  9. Patients must sign informed consent and be willing and able to comply with therequirements of visits, treatment, laboratory tests and other research requirementsstipulated in the research schedule;

Exclusion

Exclusion Criteria:

  1. Histologically confirmed keratinizing squamous cell carcinoma (WHO I)

  2. Receiving radiotherapy or chemotherapy or targeted therapy previously

  3. Women of child-bearing potential who are pregnant or breastfeeding because of thepotentially dangerous effects of the preparative chemotherapy on the fetus orinfant.

  4. Suffered from other malignant tumors (except the cure of basal cell carcinoma oruterine cervical carcinoma in situ) previously.

  5. Patients with significantly lower heart, liver, lung, kidney and bone marrowfunction.

  6. Severe, uncontrolled medical conditions and infections.

  7. At the same time using other test drugs or in other clinical trials.

  8. Refusal or inability to sign informed consent to participate in the trial.

  9. Other treatment contraindications.

  10. Emotional disturbance or mental illness, no civil capacity or limited capacity forcivil conduct.

Study Design

Total Participants: 246
Treatment Group(s): 2
Primary Treatment: CCRT+Nimotuzumab
Phase: 2
Study Start date:
January 31, 2020
Estimated Completion Date:
December 31, 2026

Study Description

Currently, although NCCN(National Comprehensive Cancer Network) guidelines recommend induction chemotherapy combined with concurrent chemoradiotherapy as IIA level-evidenced treatment for locally advanced nasopharyngeal carcinoma (stage II-IVa),there is still about 20-30% of patients with locally advanced nasopharyngeal carcinoma experienced recurrence and metastasis after radical treatment.

Our previous results showed that patients with plasma Epstein-Barr virus(EBV) DNA> 0 copy/mL or stable disease/progressive disease(SD/PD) after induction chemotherapy had a significantly higher risk of disease progression than patients with plasma EBV DNA=0 copy/mL and complete response/partial response(CR/PR),according to Response Evaluation Criteria in Solid Tumors (RECIST). As for these high-risk patients, the urgent clinical problem to be solved is whether increased treatment intensity during concurrent chemoradiotherapy can improve their survival rates.

Epidermal growth factor (EGFR) is an important therapeutic target for nasopharyngeal carcinoma.Multiple retrospective studies have shown that chemoradiotherapy combined with the EGFR blocker nimotuzumab improved the survival rate of patients with locally advanced nasopharyngeal carcinoma compared with chemoradiotherapy alone. However, phase II randomized clinical trial about the incorporation of nimotuzumab into concurrent chemoradiotherapy is still limited.

This is the first phase II randomized clinical trial of concurrent chemoradiotherapy with or without Nimotuzumab for high risk locally advanced NPC patients, determining whether concurrent chemoradiotherapy combined with nimotuzumab can improve the survival rate of high-risk patients and may provide new evidence for individualized comprehensive treatment of locally advanced nasopharyngeal carcinoma.

Connect with a study center

  • Sun Yat-sen Universitty Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

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