Could immunotherapy let surgeons do less without hurting survival?
NCT ID NCT07320690
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether people with advanced head and neck cancer who respond to immunotherapy can safely have a smaller, less invasive surgery than usual. The goal is to preserve organ function and quality of life without lowering the chance of survival. About 356 participants will be randomly assigned to either standard surgery or a reduced surgery based on post-immunotherapy tumor boundaries.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- immunotherapy (neoadjuvant) followed by de-escalation surgery
- What this could lead to
- If successful, this approach could allow many patients to have smaller, less disfiguring surgeries while still controlling their cancer.
- What could go wrong
- This is a Phase 3 trial, but it is not yet recruiting. The non-inferiority design means it aims to show that less surgery is not worse than standard surgery, but there is a risk that survival could be slightly worse.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 356 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- 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: 1. Age between 18 and 75 years inclusive, with no restriction on gender. 2. Histologically confirmed primary squamous cell carcinoma of the head and neck (excluding nasopharyngeal carcinoma). 3. Clinical stage III-IVa according to the AJCC 8th edition TNM staging system prior to immunotherapy; specifically, stage III-IVa for oropharyngeal squamous cell carcinoma (p16-negative) or stage III for oropharyngeal squamous cell carcinoma (p16-positive). 4. ECOG performance status of 0 or 1. 5. Life expectancy of ≥6 months. 6. Received preoperative immune checkpoint inhibitor therapy, primarily with anti-PD-1 monoclonal antibodies or bispecific antibodies containing an anti-PD-1 arm, regardless of brand, with or without concurrent chemotherapy or targeted therapy, for no more than six cycles. 7. Achieved complete response (CR) or partial response (PR) on imaging assessment after preoperative therapy, according to RECIST 1.1 criteria. 8. Assessed as eligible for de-escalation surgery based on clinical evaluation by the surgeon. Examples include omission of surgery on the primary lesion; preservation of critical structures or functions, such as retaining the mandible initially planned for resection; avoidance of flap reconstruction; or limitation of tongue resection to less than half when hemi-glossectomy was initially indicated. 9. No prior curative surgery or radiotherapy for the current tumor. 10. Willing to undergo surgical treatment. 11. No significant contraindications to surgery. 12. Voluntary participation in the study, signed informed consent, good compliance, and willingness to cooperate with follow-up visits. Exclusion Criteria: 1. Severe underlying diseases making the patient unable to tolerate surgery. 2. Current tumor is recurrent. 3. Myocardial infarction, severe/unstable angina, NYHA class II or higher heart failure, or symptomatic congestive heart failure within 6 months before randomization. 4. History of psychiatric drug abuse or drug addiction. 5. Pregnant or breastfeeding women. 6. Diagnosis of other malignancies within 5 years prior to study entry, except for locally treated and cured basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder carcinoma, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma. 7. Any other severe physical or mental illness, or laboratory abnormalities that might increase the risk associated with participation or interfere with the study results, or any other conditions deemed unsuitable for participation by 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 Ninth Peolple's Hospital
Shanghai, Shanghai Municipality, 200000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Blood test aims to catch Cancer's return earlier
- Can a new targeted drug outperform standard therapy for advanced head and neck cancer?
- Can Pre-Surgery immunotherapy prime the immune system to fight head and neck cancer?
- Can a new drug boost the power of chemoradiation against head and neck cancer?
- Experimental antibody combo aims to boost immune attack on head and neck tumors