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

Phase 2

Active, not recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Docetaxel and Cisplatin and Nimotuzumab

• Registration Number: NCT03708822
• Lead Sponsor: Sun Yat-sen University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-14
• Study First Submitted QC: 2018-10-14
• Study Start: 2018-10-15
• Study First Posted: 2018-10-17
• Primary Completion: 2022-07-20
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-18
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Docetaxel and Cisplatin and Nimotuzumab	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.

Primary Outcome Measures

Name	Time	Method
overall response rate	up to 18 weeks	the proportion of patients achieved partial response (PR) and complete response (CR) according to RECIST v1.1

Secondary Outcome Measures

Name	Time	Method
disease control rate	up to 18 weeks	the proportion of patients achieved CR, PR, or stable disease \[SD\]
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	time interval from the first day of documented response to progressive disease \[PD\] or death from any cause
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	time interval from the enrolled date to the documented PD or death from any cause or censored at the last follow-up
overall survival	From date of the enrollment until the date of the documented death, assessed up to 72 months	time interval from the enrolled date to death from any cause or last follow-up
adverse events	up to 18 weeks	treatment-related adverse events graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Trial Locations

Locations (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,; 🇨🇳 Guangzhou, China