Radiotherapy Plus Nimotuzumab or Cisplatin in Nasopharyngeal Carcinoma

NCT04456322 | Active Not Recruiting Phase 3

• 1 other identifier: 2020-FXY-001
• Study Type: interventional
• Target: 381
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase III randomized clinical trial of definitive radiotherapy plus EGFR blocker nimotuzumab versus radiotherapy plus cisplatin(CCRT) for nasopharyngeal carcinoma (NPC) patients with favorable response to induction chemotheray(IC), determining whether radiotherapy combined with nimotuzumab was non-inferior to CCRT and may provide new evidence for individualized comprehensive treatment of locoregionally advanced NPC.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-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 (9)

• Overall Survival (OS)

  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)

RT plus Nimotuzumab

EXPERIMENTAL

Patients with pretreatment plasma EBV DNA\<1500 copy/ml and up to CR/PR according to RECIST and the EBV DNA reduced to undectable(0 copy/mL ) 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 nimotuzumab (200mg, once a week during radiotherapy, a total of 7 weeks)

Drug: RT plus Nimotuzumab

RT plus Cisplatin

ACTIVE COMPARATOR

Patients with pretreatment plasma EBV DNA\<1500 copy/ml and up to CR/PR according to RECIST and the EBV DNA reduced to undectable(0 copy/mL ) 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) )

Drug: RT plus Cisplatin

Interventions

RT plus Nimotuzumab DRUG

Nimotuzumab (200mg, once a week during radiotherapy, a total of 7 weeks)

RT plus Nimotuzumab

RT plus Cisplatin DRUG

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

Also known as: Cisplatin

RT plus Cisplatin

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, type of WHO II or III, clinical stage II-IVa (except N3)(according to the 8th American Joint Committee on Cancer\[AJCC\] edition)
• Patients with pre-treatment plasma EBV DNA\<1500 copies/mL
• Patients with plasma EBV DNA= 0 copy/mL and CR/PR 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 (15)

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MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

nimotuzumab; Cisplatin

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)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• 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: June 30, 2020
• First Posted: July 2, 2020
• Study Start: August 17, 2020
• Primary Completion: May 11, 2024
• Study Completion (Estimated): May 11, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

CN (1)