Concurrent Chemoradiotherapy With Nimotuzumab for High Risk Nasopharyngeal Carcinoma

NCT04223024 | Active Not Recruiting Phase 2

• 1 other identifier: B2019-191
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progress-free survival (PFS)

  Defined from date of randomization to date of first documentation of progression or death due to any cause

  2 years

Secondary Outcomes (8)

• Overall Survival (OS) the last follow-up.

  2 years

• Locoregional Relapse-Free Survival (LRFS)

  2 years

• Distant Metastasis-Free Survival (DMFS)

  2 years

• Objective Response Rate (ORR)

  Three months after the completion of the CCRT with or without Nimotuzumab treatment

• Incidence rate of adverse events (AEs)

  2 years

Study Arms (2)

CCRT + Nimotuzumab

EXPERIMENTAL

Patients whose plasma EBV DNA\> 0 copy/mL or SD/PD according to RECIST after two cycle induction chemotherapy( TPF :Paclitaxel liposome135mg/m2 d1+DDP 25mg/m2 d1-d3+ 5-fu 750mg /m2/day civ120h, every 3 weeks for 2 courses) will have concurrent cisplatin (100mg/m2, every three weeks,D1,D22,D43 of intensity modulated radiotherapy) + nimotuzumab (200mg, once a week during radiotherapy, a total of 7 weeks)

Drug: CCRT+Nimotuzumab

CCRT alone

ACTIVE COMPARATOR

Patients whose plasma EBV DNA\> 0 copy/mL or SD/PD according to RECIST after two cycle induction chemotherapy( TPF :Paclitaxel liposome135mg/m2 d1+DDP 25mg/m2 d1-d3+ 5-fu 5-fu 750mg /m2/day civ120h, every 3 weeks for 2 courses) will have concurrent cisplatin (100mg/m2, every three weeks,D1,D22,D43 of intensity modulated radiotherapy) )

Drug: CCRT alone

Interventions

CCRT+Nimotuzumab DRUG

concurrent cisplatin (100mg/m2, every three weeks,D1,D22,D43 of intensity modulated radiotherapy) + Nimotuzumab (200mg, once a week during radiotherapy, a total of 7 weeks)

Also known as: Nimotuzumab

CCRT + Nimotuzumab

CCRT alone DRUG

concurrent cisplatin (100mg/m2, every three weeks,D1,D22,D43 of intensity modulated radiotherapy )

CCRT alone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70, regardless of sex.
• Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma with positive EGFR expression, type of WHO II or III, clinical stage II-IVa (according to the 8th American Joint Committee on Cancer\[AJCC\] edition)
• Patients with plasma EBV DNA\> 0 copy/mL or SD/PD according to RECIST after two cycle induction chemotherapy
• ECOG (Eastern Cooperative Oncology Group) score: 0-1
• Women in their reproductive years should ensure that they use contraception during the study period.
• Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.
• Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)\< 2.5 times the upper limit of normal value (ULN), total bilirubin \<2.0×ULN.
• Renal function: serum creatinine \<1.5×ULN
• Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule;

You may not qualify if:

• Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
• Receiving radiotherapy or chemotherapy or targeted therapy previously
• Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
• Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
• Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
• Severe, uncontrolled medical conditions and infections.
• At the same time using other test drugs or in other clinical trials.
• Refusal or inability to sign informed consent to participate in the trial.
• Other treatment contraindications.
• Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen Universitty Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (17)

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MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

nimotuzumab

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

Study Officials

• Haiqiang Mai, MD,PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department of Nasopharyngeal Carcinoma

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: January 31, 2020
• Primary Completion: August 31, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)