Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

NCT ID: NCT03708822

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2024-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Docetaxel and Cisplatin and Nimotuzumab

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.

Group Type EXPERIMENTAL

Docetaxel and Cisplatin and Nimotuzumab

Intervention Type DRUG

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) ;

Interventions

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Docetaxel and Cisplatin and Nimotuzumab

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) ;

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Qingqing Cai

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Guangzhou, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40325445 (View on PubMed)

Other Identifiers

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B2018-097-01

Identifier Type: -

Identifier Source: org_study_id

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