Can a primer drug make chemotherapy work better for frail head and neck cancer patients?
NCT ID NCT07796126
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether giving toripalimab first can prime head and neck cancer tumors to respond better to the chemotherapy drug paclitaxel. The study enrolls 22 patients with metastatic or incurable head and neck squamous cell carcinoma who have a reduced performance status, meaning they are less able to carry out daily activities. Participants receive toripalimab every three weeks, followed by weekly paclitaxel, in repeating cycles. Researchers measure how many patients see their tumors shrink or disappear, how long they live, and how the treatment affects quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- toripalimab and paclitaxel
- What this could lead to
- If it works, this could offer a new treatment option for head and neck cancer patients who are too frail for standard therapies, potentially improving response rates and survival.
- What could go wrong
- This is a small, early-phase pilot study, so results may not hold up in larger trials. The combination may cause side effects, and the benefit over standard care is not yet proven.
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
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 22 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
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 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: * Participants must have histologically confirmed HNSCC deemed to be metastatic or incurable by the treating physician. Participants can have incurable disease at presentation or have been treated with definitive curable surgical resection, chemoradiotherapy (CRT), or both, then relapsed with non-curable disease. Participants diagnosed with HNSCC stage IV-C or metastatic/non-resectable, relapsed disease are eligible for this study * Participant must have measurable disease, defined by RECIST v1.1. * Participant must be able to understand a written informed consent document and be willing to sign it. * Participants must be 18 years of age or older. * Participant must have a life expectancy of at least six months. * Participant must have an ECOG performance score of 2. * Participant must have: 1. Total bilirubin ≤ 3 times upper limit of normal (ULN) 2. Hemoglobin \> 8 g/dL. Transfusion is permitted 3. Absolute neutrophil count (ANC) \> 1.0 K/mm3. Granulocyte colony-stimulating factor (G-CSF) is NOT permitted * Paclitaxel has known embryo- and fetotoxic effects. Therefore, women of childbearing potential must agree to avoid becoming pregnant and male participants should avoid impregnating a female partner and donating sperm starting at initiation of treatment up until at least 30 days after last dose of toripalimab or paclitaxel. Exclusion Criteria: * Participants with known untreated brain metastases will be excluded from this clinical trial. Stable brain metastases will be allowed, and it will be confirmed by stable brain MRI with and without contrast within 8 weeks of signing consent. * Participants with uncontrolled chronic obstructive pulmonary disease (COPD), heart disease, or autoimmune disease, in the opinion of the treating physician. * Participants who are taking any other investigational drugs. * Participants who are taking prednisone or equivalent steroid \>10 mg per day prior to the start of treatment. * The washout period is at the treating physician's discretion. * Once participants are on study, they may be treated with steroids and other immunosuppressants per standard of care. * Participants with a history of allergic reactions attributed to toripalimab, paclitaxel, or medicines containing Kolliphor ELP (Polyoxyl 35 Castor Oil, NF). * Participants who are pregnant or breastfeeding. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued. * Participants who have end-stage renal failure are eligible for this study unless they have had a kidney transplant. * Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to follow the treatment plan.
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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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Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
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