Can a new drug boost chemotherapy for head and neck cancer?

NCT ID NCT07791745

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether adding an experimental drug called Enlituo to a standard chemotherapy combination helps people with advanced, recurrent, or metastatic head and neck squamous cell carcinoma. Participants receive either the standard combination (Anyouping plus platinum-based chemotherapy) or the same combination with Enlituo added. The study measures how well the cancer responds and how long people live, aiming to see if the extra drug improves outcomes.

What this could mean

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

Active substance
Enlituo (an experimental drug) added to Anyouping and platinum-based chemotherapy
What this could lead to
If it works, this could offer a new first-line treatment option for people with advanced head and neck cancer, potentially improving response rates and survival.
What could go wrong
The trial is in phase II/III, so results are not yet confirmed. Adding Enlituo may increase side effects without improving outcomes, and the benefit may not apply to all patients.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 362 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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: * Voluntarily sign the written informed consent form and be willing to comply with all requirements specified in the study protocol; * Aged ≥ 18 years; * Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (including oral cavity, oropharynx, hypopharynx, larynx), deemed incurable after local therapy; * Have not received any systemic therapy for recurrent or metastatic disease. Note: If disease progression occurs during neoadjuvant/adjuvant therapy, concurrent radiotherapy, or within 6 months after treatment discontinuation, the anti-tumor therapy administered during neoadjuvant/adjuvant therapy or concurrent radiotherapy (including platinum-based chemotherapy, anti-EGFR monoclonal antibodies, PD-1/PD-L1 inhibitors, etc.) will be regarded as first-line systemic therapy, and such subjects will be excluded. (Remark: Subjects previously treated with PD-1/PD-L1 inhibitors may be enrolled provided a washout period of ≥ 12 months is met.) * Have at least one measurable evaluable target lesion per RECIST v1.1, or a measurable lesion with definitive radiological progression following local therapy, and the lesion must be suitable for repeated precise measurement; * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no disease deterioration within 2 weeks prior to enrollment; * For participants with oropharyngeal carcinoma, human papillomavirus (HPV) status test results based on tumor tissue samples must be available prior to enrollment. Exclusion Criteria: * Primary tumor site (any histologic type) located in nasopharynx, nasal cavity, paranasal sinus, salivary gland, thyroid or parathyroid gland, skin, or unknown primary origin; * Participants who have been diagnosed with a malignancy other than squamous cell carcinoma of the head and neck within 3 years prior to enrollment. Exceptions include cured basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or carcinoma in situ of the cervix and/or breast cancer treated with curative resection; * Participants with an expected survival of less than 6 months and/or rapidly progressive disease (e.g., participants experiencing rapid disease progression within 1-2 months during therapy planned prior to enrollment); * Participants eligible for curative-intent local therapy; * Pregnant or breastfeeding participants, or those planning pregnancy or conception during the anticipated study period (from screening visit through 180 days after the last dose); * Known history of psychiatric disorder or substance abuse that would interfere with compliance with study requirements; * Any other condition that renders the participant unsuitable for enrollment in the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Neoplasm Metastasis Recurrence Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120, China

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