Concurrent Chemoradiotherapy With Nimotuzumab for High Risk Nasopharyngeal Carcinoma

Phase 2Active Not RecruitingNCT04223024

Sun Yat-sen University246 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

246

Conditions

Nasopharyngeal Carcinoma

Interventions

CCRT+NimotuzumabDRUG

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)

CCRT aloneDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18-70, regardless of sex. 2. 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) 3. Patients with plasma EBV DNA\> 0 copy/mL or SD/PD according to RECIST after two cycle induction chemotherapy 4. ECOG (Eastern Cooperative Oncology Group) score: 0-1 5. Women in their reproductive years should ensure that they use contraception during the 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)\< 2.5 times 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 the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule; 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 the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. 4. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously. 5. Patients with significantly lower heart, liver, lung, kidney and bone marrow function. 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 for civil conduct.

Locations (1)

Sun Yat-sen Universitty Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Progress-free survival (PFS)

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

Time frame: 2 years

Secondary Outcomes

Overall Survival (OS) the last follow-up.

Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.

Time frame: 2 years

Locoregional Relapse-Free Survival (LRFS)

Defined from date of randomization to date of first documentation of locoregional relapse or the date of death from any cause or until the date of the last follow-up visit

Time frame: 2 years

Distant Metastasis-Free Survival (DMFS)

Defined from date of randomization to date of first documentation of distant metastases or the date of death from any cause or until the date of the last follow-up visit

Time frame: 2 years

Objective Response Rate (ORR)

An objective response is defined as either a confirmed CR or a PR, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI)

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

Incidence rate of adverse events (AEs)

Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.

Data from ClinicalTrials.gov

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