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Can a targeted therapy replace harsh chemo in nasopharyngeal cancer?

NCT ID NCT04456322

Disease control Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This phase 3 trial compares two treatments for patients with a type of nasopharyngeal cancer that responded well to initial chemotherapy. Half receive standard radiotherapy plus the targeted drug nimotuzumab, while the other half receive radiotherapy plus the chemotherapy drug cisplatin. The goal is to see if nimotuzumab is at least as effective as cisplatin in preventing the cancer from progressing, while potentially offering a different side-effect profile. The study includes adults aged 18-70 with specific cancer stages and low EBV DNA levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nimotuzumab (an EGFR blocker) given weekly during radiotherapy, compared to cisplatin given every three weeks during radiotherapy.
What this could lead to
If nimotuzumab works as well as cisplatin, it could offer a less toxic treatment option for nasopharyngeal cancer, potentially improving quality of life during and after therapy.
What could go wrong
This is a phase 3 trial, but results are not yet known. Nimotuzumab might not be as effective as cisplatin, and side effects like skin reactions or infusion-related issues could occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

381 people

The number who actually took part.

Started

Aug 2020

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-70, regardless of sex. 2. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, clinical stage II-IVa (except N3)(according to the 8th American Joint Committee on Cancer\[AJCC\] edition) 3. Patients with pre-treatment plasma EBV DNA\<1500 copies/mL 4. Patients with plasma EBV DNA= 0 copy/mL and CR/PR according to RECIST after two cycle induction chemotherapy 5. ECOG (Eastern Cooperative Oncology Group) score: 0-1 6. Women in their reproductive years should ensure that they use contraception during the study period. 7. Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L. 8. Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)\< 2.5 times the upper limit of normal value (ULN), total bilirubin \<2.0×ULN. 9. Renal function: serum creatinine \<1.5×ULN 10. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule; Exclusion Criteria: 1. Histologically confirmed keratinizing squamous cell carcinoma (WHO I) 2. Receiving radiotherapy or chemotherapy or targeted therapy previously 3. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. 4. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously. 5. Patients with significantly lower heart, liver, lung, kidney and bone marrow function. 6. Severe, uncontrolled medical conditions and infections. 7. At the same time using other test drugs or in other clinical trials. 8. Refusal or inability to sign informed consent to participate in the trial. 9. Other treatment contraindications. 10. Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.

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Conditions

The condition(s) this trial relates to.

nasopharyngeal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nasopharyngeal carcinoma

Contacts and locations

Locations

  • Sun Yat-sen Universitty Cancer Center

    Guangzhou, Guangdong, 510060, China

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