Brief Title
Concurrent Chemoradiotherapy With Nimotuzumab for High Risk Nasopharyngeal Carcinoma
Official Title
Randomized Phase II Trial of Concurrent Chemoradiotherapy With or Without Nimotuzumab for High Risk Nasopharyngeal Carcinoma After Induction Chemotherapy
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.
Detailed 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progress-free survival (PFS)
Secondary Outcome
Overall Survival (OS) the last follow-up.
Condition
Nasopharyngeal Carcinoma
Intervention
CCRT+Nimotuzumab
Study Arms / Comparison Groups
CCRT + Nimotuzumab
Description: 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)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
150
Start Date
December 13, 2019
Completion Date
December 2026
Primary Completion Date
December 2022
Eligibility Criteria
Inclusion Criteria:
1. Age 18-70, regardless of sex.
2. Patients with newly histologically confirmed non-keratinizing nasopharyngeal
carcinoma, 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.
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Haiqiang Mai, MD,PhD, 86-20-87343380, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04223024
Organization ID
B2019-191
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
Haiqiang Mai, MD,PhD, Principal Investigator, Sun Yat-sen University
Verification Date
April 2020