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Head and Neck CancerPhase 4NCT06879691

A Trial of Nimotuzumab and Pinkiller Efficacy and Pain in Advanced Head and Neck Squamous Cell Carcinoma

A Phase 4 study testing Nimotuzumab, cis-platinum and IMRT combine with cisplatin concurrent chemotherapy in people with Head and Neck Cancer, run by Biotech Pharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to investigate the impact of combining Nimotuzumab with analgesic agents on pain management outcomes, as well as the effectiveness and safety profile of this therapeutic combination in the comprehensive treatment of locally advanced head and neck squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
Nimotuzumab, cis-platinum and IMRT combine with cisplatin concurrent chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
1 siteChina
Study dates
15 May 2021to 14 Apr 2025
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 years, inclusive of 18 years but exclusive of 75 years.
  • ECOG Performance Status (PS) score 0-2.
  • Histologically or cytologically confirmed Stage III-IVb (according to the 2020 CSCO Guidelines for Diagnosis and Treatment of Head and Neck Tumors) squamous cell carcinoma of the head and neck (including oral, oropharyngeal, hypopharyngeal, and laryngeal cancers; excluding nasopharyngeal carcinoma).
  • EGFR-positive expression confirmed by immunohistochemistry.
  • Patients deemed ineligible for surgery (due to physical contraindications or refusal of surgery).
  • At least one measurable lesion according to RECIST 1.1 criteria:
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  • CT scan ≥10 mm (tumors not measurable by calipers should be recorded as non-measurable).
  • Chest X-ray ≥20 mm. Pathologically enlarged lymph nodes: short-axis ≥15 mm on CT scan (slice thickness ≤5 mm).
  • Suitable for comprehensive treatment with curative or palliative intent. ●Baseline pain assessment: Numeric Rating Scale (NRS) score ≥1. Patients not previously treated with opioids who are candidates for opioid therapy.
  • Patients on weak opioids with inadequate pain control requiring escalation to strong opioids.
  • Patients with moderate-to-severe cancer pain on strong opioids with inadequate control.
  • Patients requiring urgent intervention due to poorly controlled pain.
  • Expected survival ≥3 months.
  • Adequate hematologic function:
  • White blood cell count ≥4×10^9/L. Absolute neutrophil count ≥1.5×10^9/L. Platelets ≥100×10^9/L. Hemoglobin ≥90 g/L.
  • ●Adequate renal function: Serum creatinine ≤1.2 mg/dL or creatinine clearance ≥60 mL/min.
  • ●Adequate hepatic function: Total bilirubin ≤1.5×ULN (≤3.0×ULN if liver metastases present). AST and ALT ≤2.5×ULN (≤5.0×ULN if liver metastases present).
  • Negative urine pregnancy test for female patients of childbearing potential (excludes those with bilateral oophorectomy, hysterectomy, or postmenopausal status).
  • Signed informed consent.

Who cannot join

  • Received radiotherapy, chemotherapy, monoclonal antibody therapy, oral EGFR-TKI therapy, anti-angiogenic agents, or immunosuppressants within the past 6 months.
  • Participation in another interventional clinical trial within 30 days prior to screening.
  • Presence of distant metastases.
  • History of other malignancies (except cured cervical carcinoma in situ, basal cell carcinoma of the skin, or malignancies cured ≥5 years prior).
  • Uncontrolled comorbidities (e.g., heart failure, diabetes, hypertension, thyroid disorders, psychiatric diseases).
  • Active HIV infection, viral hepatitis, or severe active infections (>Grade 2 per CTCAE v5.0).
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  • Chronic steroid therapy (>10 mg/day prednisone equivalent for >6 months).
  • Known hypersensitivity to any component of the study drugs.
  • ●≥Grade 2 peripheral neuropathy or hearing loss (per NCI CTCAE v5.0).
  • Pregnancy, lactation, or refusal to use effective contraception (for both male and female participants) until 6 months after the last treatment.
  • Investigator judgment of unsuitability for the study.
  • Unwillingness or inability to provide informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Baotou Cancer Hospital

    Baotou, Inner Mongolia, 014000

Other trials in China

About this study

Official title: A Randomized Controlled Trial on the Efficacy and Pain Impact of Nimotuzumab Combined with a Painkiller in Comprehensive Treatment of Advanced Squamous Cell Carcinoma of Head and Neck

The purpose of this study is to investigate the impact of combining Nimotuzumab with analgesic agents on pain management outcomes, as well as the effectiveness and safety profile of this therapeutic combination in the comprehensive treatment of locally advanced head and neck squamous cell carcinoma.

Read the detailed description

The study is an open-label, randomized controlled phase II clinical trial designed to evaluate the impact of Nimotuzumab combined with analgesic therapy on pain management outcomes, as well as the therapeutic efficacy and safety profile of this combination in the comprehensive treatment of locally advanced head and neck squamous cell carcinoma.

Eligible participants will be randomly assigned to either the experimental group or the control group. Patients in the experimental group will receive Nimotuzumab plus analgesic therapy in addition to concurrent radiochemotherapy, while those in the control group will undergo analgesic therapy combined with concurrent radiochemotherapy alone.

Being tested
Nimotuzumab, cis-platinum, IMRT combine with cisplatin concurrent chemotherapy, painkiller
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NimotuzumabDrug

    Also called H-R3

    nimotuzumab group nimotuzumab, 200mg/w, for 6 weeks

  • cis-platinumDrug

    Also called cisplatin

    30mg/m2/w, for 6 weeks

  • IMRT combine with cisplatin concurrent chemotherapyRadiation

    IMRT, 66～70Gy (2Gy/F, 35F), for 6 weeks

  • painkillerDrug

    three ladders pain analgesic( First step: For mild pain, non-opioid agents (excluding nonsteroidal anti-inflammatory drugs [NSAIDs]) combined with adjuvant analgesics are administered; Second step: For moderate pain, weak opioids combined with NSAIDs and adjuvant analgesics are prescribed;Third step: For severe pain, strong opioids combined with NSAIDs and adjuvant analgesics are used.)

Study groups in NCT06879691
Study groupRoleWhat they receive
nimotuzumab groupExperimentalnimotuzumab, 200mg/w, for 6 weeks cis-platinum, 30mg/m2/w, for 6 weeks IMRT, 66～70Gy (2Gy/F, 35F), for 6 weeks painkiller, three ladders pain analgesic
Receives: Drug: Nimotuzumab; Drug: cis-platinum; Radiation: IMRT combine with cisplatin concurrent chemotherapy; Drug: painkiller
control groupOthercis-platinum, 30mg/m2/w, for 6 weeks IMRT, 66～70Gy (2Gy/F, 35F), for 6 weeks painkiller, three ladders pain analgesic
Receives: Drug: cis-platinum; Radiation: IMRT combine with cisplatin concurrent chemotherapy; Drug: painkiller

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-year PFS rate

    Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by INV per RECIST v1.1.cause,whichever occurs first.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Secondary outcomes (2)

  1. NRS score

    NRS score, also known as numerical scoring method, is a commonly used method for assessing pain levels. It uses a straight line or scale to allow patients to choose a number based on their personal pain perception, ranging from 0 (painless) to 10 (most painful) to indicate the degree of pain.

    Measured: Baseline, during concurrent radiochemotherapy (weeks 1,6), post-intervention (week 7), every 3 months for first 2 years, then every 6 months thereafter (through study completion, average 4 years).

  2. OS

    Refers to the time from randomization to death caused by any reason.

    Measured: From randomization to death from any cause (up to approximately 36 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2025
  2. Study start15 May 2021
  3. Primary completion14 Apr 2025 (estimated)
  4. Study completion14 Apr 2025 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
171 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06879691
Sponsor's protocol ID
IST-Nimo-N&C-2021-03
Status last verified
Mar 2025
First submitted
24 Feb 2025
Last updated
17 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nimotuzumab, cis-platinum and IMRT combine with cisplatin concurrent chemotherapy in people with Head and Neck Cancer, run by Biotech Pharmaceutical Co., Ltd. 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 19 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

2-year PFS rate (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months). 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 NCT06879691.

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 17 Mar 2025.

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