deltatrials
Unknown PHASE3 INTERVENTIONAL 2-arm NCT01074021

Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer

A Prospective,Randomized,Double-Blind,Controlled,Multicenter,Phase III Study of Nimotuzumab in Combination With Chemotherapy and Radiotherapy for Patients With Local Advanced Nasopharyngeal Cancer

Sponsor: Biotech Pharmaceutical Co., Ltd.

Updated 8 times since 2017 Last updated: Oct 28, 2015 Started: Oct 31, 2009 Primary completion: May 31, 2016 Completion: Aug 31, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Nasopharyngeal Cancer and is currently ongoing. Biotech Pharmaceutical Co., Ltd. leads this study, which shows 8 recorded versions since 2009 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

Patients with advanced nasopharyngeal cancer will be randomized to 2 arms. The patients in experimental arm will be treated with Nimotuzumab which will be used concurrently with radiotherapy and chemotherapy. The chemotherapy regimen were Cisplatin monotherapy. The active comparator arm will be administered chemotherapy and radiotherapy only. The dose and regimen were the same with experiment arm. The patients'hematopoietic , hepatic and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed at the first and the fourth month, and followup every six months to evaluate the survival index in three years after the study.

Patients with advanced nasopharyngeal cancer will be randomized to 2 arms. The patients in experimental arm will be treated with Nimotuzumab which will be used concurrently with radiotherapy and chemotherapy. The chemotherapy regimen were Cisplatin monotherapy. The active comparator arm will be administered chemotherapy and radiotherapy only. The dose and regimen were the same with experiment arm. The patients'hematopoietic , hepatic and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed at the first and the fourth month, and followup every six months to evaluate the survival index in three years after the study.

Status Flow

~Jan 2017 – ~Sep 2017 · 8 months · monthly snapshotActive Not Recruiting~Sep 2017 – ~Jun 2018 · 9 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotUnknown~Sep 2025 – present · 7 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown PHASE3

  2. Sep 2025 — Present [monthly]

    Unknown PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Unknown PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE3

    Status: Unknown StatusUnknown

  5. Jan 2021 — Jul 2024 [monthly]

    Unknown Status PHASE3

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Unknown Status PHASE3

  2. Sep 2017 — Jun 2018 [monthly]

    Unknown Status PHASE3

    Status: Active Not RecruitingUnknown Status

  3. Jan 2017 — Sep 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Oct 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Biotech Pharmaceutical Co., Ltd.
Data source: Biotech Pharmaceutical Co., Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .