Nasopharyngeal CarcinomaPhase 2NCT03708822
Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
A Phase 2 study testing Docetaxel and Cisplatin and Nimotuzumab in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of docetaxel and cisplatin combined with Nimotuzumab in the treatment of recurrent and metastatic nasopharyngeal carcinoma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Docetaxel and Cisplatin and Nimotuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2018to 30 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- biopsy proved nasopharyngeal carcinoma;
- stage IVB according to the eighth edition American Joint Committee on Cancer/Union for International Cancer Control staging system, or recurrent disease beyond more than 6 months after curative chemotherapy and/or radiotherapy;
- 18-70 years;
- without other malignancy;
- had at least one measurable disease;
- had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- estimated life expectancy exceeding 3 months;
- adequate functions of the major organs.
Who cannot join
- allergic to docetaxel or cisplatin or nimotuzumab;
- pregnant or lactating female;
- patients received other clinical trails within 3 months;
- had serious infections, comorbidities or vital organs dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,
Guangzhou, 51000
About this study
Official title: Open-Label, Multicenter, Phase Ⅱ Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of docetaxel and cisplatin combined with Nimotuzumab in the treatment of recurrent and metastatic nasopharyngeal carcinoma
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Docetaxel and Cisplatin and Nimotuzumab
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel and Cisplatin and NimotuzumabDrug
Intravenous nimotuzumab (200 mg on days 1, 8, and 15) ; Intravenous docetaxel (75 mg/m2 on day 1) ; Intravenous cisplatin (75 mg/m2 on day 1) ;
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel and Cisplatin and Nimotuzumab | Experimental | All eligible patients received intravenous nimotuzumab plus docetaxel and cisplatin every 3 weeks for a maximum of 6 cycles, or until disease progression, death, intolerable toxicity. Receives: Drug: Docetaxel and Cisplatin and Nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
the proportion of patients achieved partial response (PR) and complete response (CR) according to RECIST v1.1
Measured: up to 18 weeks
Secondary outcomes (5)
disease control rate
the proportion of patients achieved CR, PR, or stable disease [SD]
Measured: up to 18 weeks
duration of response
time interval from the first day of documented response to progressive disease [PD] or death from any cause
Measured: From date of documented response until the date of progressive disease [PD] or death, whichever came first, assessed up to 12 months
progression-free survival
time interval from the enrolled date to the documented PD or death from any cause or censored at the last follow-up
Measured: From date of the enrollment until the date of the documented PD or death, whichever came first, assessed up to 12 months
overall survival
time interval from the enrolled date to death from any cause or last follow-up
Measured: From date of the enrollment until the date of the documented death, assessed up to 72 months
adverse events
treatment-related adverse events graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Measured: up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start15 Oct 2018
- Primary completion20 Jul 2022
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708822
- Sponsor's protocol ID
- B2018-097-01
- Status last verified
- Jan 2024
- First submitted
- 14 Oct 2018
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zou Q, Cao Y, Lai Y, Fang Y, Zhang Y, Liu P, Lu L, Wu H, Huang T, Su N, Li Z, Wang X, Tian X, Li L, Liu Y, Cai Q, Xia Y. Nimotuzumab combined with docetaxel and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma: a multicenter, phase 2 trial. BMC Med. 2025 May 6;23(1):264. doi: 10.1186/s12916-025-04103-0.
PubMed 40325445
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Multicenter, Phase Ⅱ Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03708822
- Acronym / sponsor ID
- B2018-097-01
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 17 Oct 2018 (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.
The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of docetaxel and cisplatin combined with Nimotuzumab in the treatment of recurrent and metastatic nasopharyngeal carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel and Cisplatin and Nimotuzumab | Experimental | Drug: Docetaxel and Cisplatin and NimotuzumabAll eligible patients received intravenous nimotuzumab plus docetaxel and cisplatin every 3 weeks for a maximum of 6 cycles, or until disease progression, death, intolerable toxicity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- biopsy proved nasopharyngeal carcinoma;
- stage IVB according to the eighth edition American Joint Committee on Cancer/Union for International Cancer Control staging system, or recurrent disease beyond more than 6 months after curative chemotherapy and/or radiotherapy;
- 18-70 years;
- without other malignancy;
- had at least one measurable disease;
Key exclusion criteria (4 listed)
- allergic to docetaxel or cisplatin or nimotuzumab;
- pregnant or lactating female;
- patients received other clinical trails within 3 months;
- had serious infections, comorbidities or vital organs dysfunction.
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 |
|---|---|---|
| Docetaxel and Cisplatin and NimotuzumabIntravenous nimotuzumab (200 mg on days 1, 8, and 15) ; Intravenous docetaxel (75 mg/m2 on day 1) ; Intravenous cisplatin (75 mg/m2 on day 1) ; | Drug | Docetaxel and Cisplatin and Nimotuzumab |
Primary outcome
overall response rate
Time frame: up to 18 weeks
the proportion of patients achieved partial response (PR) and complete response (CR) according to RECIST v1.1
5 secondary outcomes
disease control rate
Time frame: up to 18 weeks
duration of response
Time frame: From date of documented response until the date of progressive disease [PD] or death, whichever came first, assessed up to 12 months
progression-free survival
Time frame: From date of the enrollment until the date of the documented PD or death, whichever came first, assessed up to 12 months
overall survival
Time frame: From date of the enrollment until the date of the documented death, assessed up to 72 months
adverse events
Time frame: up to 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 40325445Zou Q, Cao Y, Lai Y, Fang Y, Zhang Y, Liu P, Lu L, Wu H, Huang T, Su N, Li Z, Wang X, Tian X, Li L, Liu Y, Cai Q, Xia Y. Nimotuzumab combined with docetaxel and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma: a multicenter, phase 2 trial. BMC Med. 2025 May 6;23(1):264. doi: 10.1186/s12916-025-04103-0.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Cisplatin and Nimotuzumab in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: up to 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03708822, which also lists 1 linked publication.
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 18 Jan 2024.