NCT03708822

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

3.8 years

First QC Date

October 14, 2018

Last Update Submit

January 16, 2024

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    the proportion of patients achieved partial response (PR) and complete response (CR) according to RECIST v1.1

    up to 18 weeks

Secondary Outcomes (5)

  • disease control rate

    up to 18 weeks

  • duration of response

    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

    From date of the enrollment until the date of the documented PD or death, whichever came first, assessed up to 12 months

  • overall survival

    From date of the enrollment until the date of the documented death, assessed up to 72 months

  • adverse events

    up to 18 weeks

Study Arms (1)

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.

Drug: Docetaxel and Cisplatin and Nimotuzumab

Interventions

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) ;

Docetaxel and Cisplatin and Nimotuzumab

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,

Guangzhou, 51000, China

Location

Related Publications (1)

  • 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.

    PMID: 40325445DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

DocetaxelCisplatinnimotuzumab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

October 14, 2018

First Posted

October 17, 2018

Study Start

October 15, 2018

Primary Completion

July 20, 2022

Study Completion

June 30, 2024

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations

CN(1)