New chemo combo shows promise for tough head and neck cancers
NCT ID NCT07662746
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing a special form of the chemotherapy drug paclitaxel, called polymeric micelles, combined with carboplatin in 29 people with recurrent or metastatic head and neck squamous cell carcinoma. The goal is to see how well the treatment shrinks tumors and to monitor side effects. Participants receive the drugs intravenously every three weeks, continuing as long as the cancer does not worsen and side effects are manageable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- paclitaxel polymeric micelles (a form of chemotherapy) plus carboplatin
- What this could lead to
- If this works, it could offer a new chemotherapy option for people with head and neck cancer that has come back or spread.
- What could go wrong
- This is a small, early-phase trial with only 29 participants, so results may not apply to everyone. Chemotherapy side effects can be severe, and the treatment may not shrink tumors as hoped.
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 29 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 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 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: * Age ≥18 and ≤75 years, male or female; Histologically or cytologically confirmed head and neck squamous cell carcinoma; Prior first-line systemic therapy (including chemotherapy, targeted therapy, and immunotherapy) with disease progression or judged by the clinician to no longer derive clinical benefit; ECOG performance status score of 0-2 and a life expectancy of at least 3 months; At least one measurable lesion on imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1, Appendix 3); Adequate major organ function, with subjects meeting the following laboratory parameters: Complete blood count meeting the following criteria (no blood transfusion, blood products, granulocyte colony-stimulating factor, or other hematopoietic growth factors within 7 days prior to the test): WBC ≥3.0×10\^9/L, ANC ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥90 g/L; Blood biochemistry meeting the following criteria: total bilirubin ≤1.5×ULN, AST, ALT, or ALP ≤2.5×ULN (for subjects with liver metastases, ALT, AST, or ALP ≤5×ULN is permitted; for subjects with bone metastases, ALP ≤10×ULN is permitted); serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula, Appendix 4) ≥50 mL/min; Adequate coagulation function, defined as INR ≤1.5×ULN and PT or APTT ≤1.5×ULN; Subjects of childbearing potential must agree to use highly effective contraceptive measures during the trial. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of chemotherapy; Good compliance, able to undergo treatment and follow-up, and willing to comply with the study requirements; voluntary signing of the informed consent form. Exclusion Criteria: * Known allergy or intolerance to any study treatment or any excipient; Presence of uncontrolled serious medical conditions, such as severe comorbidities including severe cardiac disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.; Other malignancies within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, or ductal carcinoma in situ after radical surgery; Requirement for concomitant use of other antineoplastic drugs; Receipt of any other investigational drug or participation in another interventional clinical trial within 30 days prior to screening; History of psychotropic substance abuse with inability to abstain, or presence of psychiatric disorders; Pregnant or breastfeeding women; Patients deemed unsuitable for enrollment 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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the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, Shanghai Municipality, 200011, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Re-irradiation plus cetuximab targets head and neck tumors that return
- Sharper tumor maps: PET scans could tighten radiation beams
- Five days of radiation instead of weeks: a new test for head and neck cancer
- Can an online program ease the burden on cancer caregivers?