Can a new drug boost chemotherapy for head and neck cancer?
NCT ID NCT07791745
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 362 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2032
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120, China
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