Nasopharyngeal Carcinoma by AJCC V8 StageNCT05717790
Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma
A study testing Nimotuzumab, Gemcitabine and Cisplatin in people with Nasopharyngeal Carcinoma by AJCC V8 Stage, run by Fourth Affiliated Hospital of Guangxi Medical University at 9 sites in China.
Trial summary
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma by AJCC V8 Stage
- What is being tested?
- Nimotuzumab, Gemcitabine and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 9 sitesChina
- Study dates
- 1 Dec 2022to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 70.
- Pathological type: non-keratinizing carcinoma (World Health Organization criteria).
- Diagnosed with LANPC (stage III-IV, except for patients with T3N0)) according to the 8th edition clinical staging system of the American Joint Committee on Cancer [AJCC]/Union for International Cancer Control [UICC].
- ECOG performance score: 0 to 1.
- Primary lesions can measurable.
- Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
- Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula).
- 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.
Who cannot join
- Primary lesions or lymph node have been operated (except of operation for biopsy).
- Previous Received other anti EGFR monoclonal antibody treatment;Previous chemotherapy or immunization therapy.
- Other malignant tumor.
- Participation in other interventional clinical trials within 1 month.
- History of Serious lung or heart disease.
- Pregnant or breast-feeding women and women who refused to take contraceptive method.
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- Drug abuse or alcohol addiction.
- History of serious allergic or allergy.
- Refused or can't signed informed consent form.
- Other patients who are considered ineligible for the study by the investigator.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
People's Hospital of Baise
Baise City, Guangxi, 533000
Yiliang Meng, 337468010@qq.com
- Recruiting
Affiliated Hospital of Youjiang Medical University for Nationalities
Baise City, Guangxi, 533099
Tingzhuang Yi, ytz20070101@163.com
- Recruiting
Guilin Medical University, China
Guilin, Guangxi, 541000
Meilian Liu, liu.meilian@163.com
- Recruiting
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Guilin, Guangxi, 541000
Dongmei Wu, wudongmei06@163.com
- Recruiting
the Fourth Affiliated Hospital of Guangxi Medical University
Liuzhou, Guangxi
Xishan Chen, Master, 344135841@qq.com
- Recruiting
Liuzhou People's Hospital
Liuzhou, Other (Non U.s.), 545000
Jun Wang, wjszr2018@126.com
- Recruiting
Second Affiliated Hospital of Guangzhou Medical University
Nanjing, Guangxi, 530000
Jian Li, 13978896800@163.com
- Recruiting
The First People's Hospital of Qinzhou
Qinzhou, Guangxi, 535000
Baoqing Yang, 460200267@qq.com
- Recruiting
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, 543000
Jianquan Gao, gjq2369712@sina.com
About this study
Official title: Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation and Adjuvant Therapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. This is a multi-center, randomized controlled trial, with the purpose to evaluate the therapeutic efficacy and safety of nimotuzumab combined with induction chemotherapy plus chemoradiation and adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma.
- Being tested
- Nimotuzumab, Gemcitabine, Cisplatin, Intensity-modulated radiotherapy
- Keywords
- Nimotuzumab, Nasopharyngeal Carcinoma, Induction Chemotherapy, Chemoradiation, Adjuvant Therapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Also called h-R3, BIOMAb EGFR
Drug: Nimotuzumab Experimental: Nimotuzumab arm Induction chemotherapy:Nimotuzumab 200mg will be given weekly for 6 cycles, started on day 1 of induction chemotherapy.
Concurrent chemotherapy: Nimotuzumab 200mg/week in concurrent with IMRT. Adjuvant therapy: Nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles.
Active Comparator: Control Nimotuzumab 200mg/week in concurrent with IMRT .
GemcitabineDrug
Also called GEM
Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 2 cycles
CisplatinDrug
Also called DDP
Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles.
Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.
Intensity-modulated radiotherapyRadiation
Also called IMRT
Definitive IMRT of 68-78 Gy, 30-33 fractions, 5 fractions/week, 1 fraction/day
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Nimotuzumab arm | Experimental | Patients will receive induction chemotherapy with nimotuzumab (200mg/w,weekly plus gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 2 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent nimotuzumab (200mg/w,weekly, 6-7 weeks) and cisplatin (100mg/m2,every 3 weeks for 3cycles )will be administered during IMRT. After 4-6 weeks of the completion of IMRT, adjuvant nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles. Receives: Drug: Nimotuzumab; Drug: Gemcitabine; Drug: Cisplatin; Radiation: Intensity-modulated radiotherapy |
| Control | Active comparator | Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 2 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent nimotuzumab (200mg/w,weekly, 6-7 weeks) and cisplatin (100mg/m2,every 3 weeks for 3cycles )will be administered during IMRT. Receives: Drug: Nimotuzumab; Drug: Gemcitabine; Drug: Cisplatin; Radiation: Intensity-modulated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival(OS)
Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.OS will be measured by the Method of Kaplan and Meier.
Measured: 5 years
Secondary outcomes (6)
Tumor control probability (TCP)
Tumor control probability is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Measured: 5 years
Disease-free survival(DFS)
DFS is defined as the time from randomization to the first documented disease progression or death due to disease progression per RECIST 1.1. DFS will be measured by the Method of Kaplan and Meier.
Measured: 5 years
Locoregional failure-free survival(LRRFS)
LRRFS is defined as the time from randomization to the date of locoregional relapse per RECIST 1.1. LRRFS will be measured by the Method of Kaplan and Meier.
Measured: 5 years
Distant Metastasis-free survival(DMFS)
DMFS is defined as the time from randomization to the date of first distant metastasis. DMFS will be measured by the Method of Kaplan and Meier.
Measured: 5 years
Incidence rate of investigator-reported adverse events (AEs)
Analysis of investigator-reported adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0 and radiation therapy oncology group (RTOG) toxicity criteria.
Measured: 5 years
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Dec 2022
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma by AJCC V8 StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fourth Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Baise, Second Affiliated Hospital of Guangzhou Medical University, People's Hospital of Guangxi Zhuang Autonomous Region, Guilin Medical University, China, LiuZhou People's Hospital, The First People's Hospital of Qinzhou, Wuzhou Red Cross Hospital, Youjiang Medical College for Nationalities
- Responsible party
- Sponsor
- Investigators
- Ying Lu, MD, Principal investigator, Fourth Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717790
- Sponsor's protocol ID
- ZLK3815405
- Status last verified
- Dec 2022
- First submitted
- 24 Dec 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Complete de-identified patient data set
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation and Adjuvant Therapy in Locoregionally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT05717790
- Acronym / sponsor ID
- ZLK3815405
- Keywords
- Nimotuzumab, Nasopharyngeal Carcinoma, Induction Chemotherapy, Chemoradiation, Adjuvant Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Fourth Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- People's Hospital of Baise, Second Affiliated Hospital of Guangzhou Medical University, People's Hospital of Guangxi Zhuang Autonomous Region, Guilin Medical University, China, LiuZhou People's Hospital, The First People's Hospital of Qinzhou, Wuzhou Red Cross Hospital, Youjiang Medical College for Nationalities
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. This is a multi-center, randomized controlled trial, with the purpose to evaluate the therapeutic efficacy and safety of nimotuzumab combined with induction chemotherapy plus chemoradiation and adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Nimotuzumab arm | Experimental | Drug: Nimotuzumab, Drug: Gemcitabine, Drug: Cisplatin, Radiation: Intensity-modulated radiotherapyPatients will receive induction chemotherapy with nimotuzumab (200mg/w,weekly plus gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 2 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent nimotuzumab (200mg/w,weekly, 6-7 weeks) and cisplatin (100mg/m2,every 3 weeks for 3cycles )will be administered during IMRT. After 4-6 weeks of the completion of IMRT, adjuvant nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles. |
| Control | Active comparator | Drug: Nimotuzumab, Drug: Gemcitabine, Drug: Cisplatin, Radiation: Intensity-modulated radiotherapyPatients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 2 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent nimotuzumab (200mg/w,weekly, 6-7 weeks) and cisplatin (100mg/m2,every 3 weeks for 3cycles )will be administered during IMRT. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18 to 70.
- Pathological type: non-keratinizing carcinoma (World Health Organization criteria).
- Diagnosed with LANPC (stage III-IV, except for patients with T3N0)) according to the 8th edition clinical staging system of the American Joint Committee on Cancer [AJCC]/Union for International Cancer Control [UICC].
- ECOG performance score: 0 to 1.
- Primary lesions can measurable.
Key exclusion criteria (10 listed)
- Primary lesions or lymph node have been operated (except of operation for biopsy).
- Previous Received other anti EGFR monoclonal antibody treatment;Previous chemotherapy or immunization therapy.
- Other malignant tumor.
- Participation in other interventional clinical trials within 1 month.
- History of Serious lung or heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NimotuzumabAlso: h-R3, BIOMAb EGFRDrug: Nimotuzumab Experimental: Nimotuzumab arm Induction chemotherapy:Nimotuzumab 200mg will be given weekly for 6 cycles, started on day 1 of induction chemotherapy. Concurrent chemotherapy: Nimotuzumab 200mg/week in concurrent with IMRT. Adjuvant therapy: Nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles. Active Comparator: Control Nimotuzumab 200mg/week in concurrent with IMRT . | Drug | Control, Experimental: Nimotuzumab arm |
| GemcitabineAlso: GEMGemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 2 cycles | Drug | Control, Experimental: Nimotuzumab arm |
| CisplatinAlso: DDPCisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles. Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles. | Drug | Control, Experimental: Nimotuzumab arm |
| Intensity-modulated radiotherapyAlso: IMRTDefinitive IMRT of 68-78 Gy, 30-33 fractions, 5 fractions/week, 1 fraction/day | Radiation | Control, Experimental: Nimotuzumab arm |
Primary outcome
overall survival(OS)
Time frame: 5 years
Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.OS will be measured by the Method of Kaplan and Meier.
6 secondary outcomes
Tumor control probability (TCP)
Time frame: 5 years
Disease-free survival(DFS)
Time frame: 5 years
Locoregional failure-free survival(LRRFS)
Time frame: 5 years
Distant Metastasis-free survival(DMFS)
Time frame: 5 years
Incidence rate of investigator-reported adverse events (AEs)
Time frame: 5 years
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Yes. Complete de-identified patient data set
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ying Lu, MD principal investigator
Fourth Affiliated Hospital of Guangxi Medical University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nimotuzumab, Gemcitabine and Cisplatin in people with Nasopharyngeal Carcinoma by AJCC V8 Stage, run by Fourth Affiliated Hospital of Guangxi Medical University at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Lu, MD (+8607723815405, 1786734840@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival(OS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023; AzTrials last refreshed its copy on 26 Oct 2026.