Toripalimab with Chemotherapy for Sinus Cancer
This study is testing a combination of treatments for sinonasal cancer (cancer of the nasal cavity or sinuses). It combines an immunotherapy drug called Toripalimab with chemotherapy drugs, Carboplatin and Docetaxel, given before surgery. Toripalimab works by boosting your immune system to fight cancer cells. The study aims to see how well this combination shrinks tumors and how safe it is. You may be able to join if you have locally advanced sinonasal squamous cell carcinoma or sinonasal undifferentiated carcinoma. Researchers will measure how much the tumor shrinks after treatment. The study plans to enroll about 20 people, but its current status is unclear.
- Study design
- This is a single-arm, open-label study, meaning all participants receive the same treatment and everyone knows which treatment is being given. It is a Phase II study and plans to enroll about 20 participants.
- What's involved
- You would undergo screening for eligibility, in-clinic visits, questionnaires, blood tests, urine tests, X-rays, CT scans, MRI scans, PET scans, and photographic images of tumors.
- Compensation
- Not stated in the trial record.
- Follow-up
- Tumor assessments or scans will be obtained at baseline and 3 months following the end of treatment.
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NCT06940180
Toripalimab With Chemotherapy for Sinus Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentGlenn J. HannaInvestigator-initiated
~20 participants
Updated 2025-06-26 on ClinicalTrials.gov
What's tested:ToripalimabCarboplatinDocetaxelRadiation TherapyCisplatin
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathologic Treatment Response Rate (pTRR)
Measured over Tumor assessments or scans will be obtained at baseline and 3-months following the end of treatment. Treatment duration is not fixed and this observation time is variable, criteria for discontinuation is outlined in protocol section 5.10.
Conditions
Where it's being run
2 sites across 1 statesMassachusetts2
Study leadership
- Glenn J Hanna, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants must have histologically or cytologically confirmed locoregionally advanced nasal cavity or paranasal sinus cancer including the following histologic subtypes: squamous cell carcinoma (SCC) of any morphologic variation: verrucous, papillary, basaloid, spindle cell, and adenosquamous; or sinonasal undifferentiated carcinoma (SNUC).
Participants with SCC should have resectable disease at baseline per the discretion of the treating surgical oncologist(s). \*Participants with SNUC can have operable or borderline resectable (definition: resection would been morbid requiring extensive surgery and would have chances of incomplete gross total resection) disease as judged by the treating surgical oncologist(s).
Participants must have clinical stage disease as defined below using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC):
T2, N1-3 III
T3, any N III, IVA, IVB
T4, any N IVA, IVB
Participants must be willing to provide blood and tissue pre-treatment and at the time of surgery for pathologic and correlative analyses.
Age 18 years or older at the time of informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Participants must have adequate organ and marrow function as defined below:
Absolute neutrophil count ≥1000/mcL
Platelets ≥100
Total bilirubin ≤institutional upper limit of normal (ULN)
AST(SGOT) / ALT (SGPT) ≤3x ULN
Creatinine ≤institutional ULN or GFR of ≥50 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2
Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Contraception use should be maintained until at least 6 months after the last dose of chemotherapy for females and 3 months for males. In addition, contraception use should continue until 4 months after last dose of toripalimab for both males and females.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion
Participants with nasal cavity or paranasal sinus malignancies demonstrating histologies other than SCC or SNUC in the opinion of the reviewing pathologist. Excluded subtypes include: angiosarcomas, rhabdomyosarcomas, lymphomas, olfactory neuroblastomas (esthesioneuroblastomas), melanomas, and meningiomas among others. SNEC or sinonasal neuroendocrine carcinoma is not permitted.
Participants with unresectable or inoperable disease as judged by the treating surgical oncologist(s).
Participants with known distant metastatic disease (M1 or IVC).
Has received prior therapy with an anti-PD-1/L1 agent or any other agent directed to another stimulatory or co-inhibitory T-cell receptor.
Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Non-live vaccines are permitted.
Carries a diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Exceptions may be permitted at the discretion of the overall Sponsor-Investigator.
Has an active autoimmune disease that has required systemic treatment in past 6 months (with use of a disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted.
Has a history of (non-infectious) pneumonitis or interstitial lung disease that required steroids or has current pneumonitis or interstitial lung disease.
Has a known history of human immunodeficiency virus (HIV) infection that is uncontrolled. No HIV testing is required unless mandated by local health authority. Patients with well controlled HIV may be eligible if their CD4 T cell count is favorable and their HIV viral load is undetectable.
Has a known history of active Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
Has a history of allogeneic tissue or solid organ transplant.
Women who are pregnant or breastfeeding.
What this trial measures
- Pathologic Treatment Response Rate (pTRR)Tumor assessments or scans will be obtained at baseline and 3-months following the end of treatment. Treatment duration is not fixed and this observation time is variable, criteria for discontinuation is outlined in protocol section 5.10.
pTRR is defined as the proportion of participants that experience a complete pathologic response or partial pathologic response during treatment, as defined in the RECIST criteria.