Actively Recruiting
Neoadjuvant Toripalimab or Toripalimab in Combination With Carboplatin and Nab-paclitaxel in Untreated HNSCC (HNSCC-002)
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-04-14
57
Participants Needed
1
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This proposed study will evaluate the efficacy and safety of preoperative administration of Toripalimab or Toripalimab combined with nab-paclitaxel and carboplatin in Head and Neck Squamous Cell Carcinoma (HNSCC) who are about to undergo surgery，and it will be helpful for comprehensive exploratory characterization of tumor immune microenvironment and circulating immune cells in these patients. Data obtained in this trial will provide valuable information for planning further prospective clinical trials of anti-PD-1 and other immunotherapies in HNSCC. We are also eager to identify potential biomarkers of response and toxicity that will enable patients with HNSCC who are most likely to benefit to receive anti-PD-1 therapy and, to the contrary, reduce the risk of toxicity and ineffective therapy in patients who are less likely to benefit from it.
CONDITIONS
Official Title
Neoadjuvant Toripalimab or Toripalimab in Combination With Carboplatin and Nab-paclitaxel in Untreated HNSCC (HNSCC-002)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed Head and Neck Squamous Cell Carcinoma planned for curative surgery
- Age between 18 and 79 years at study entry
- ECOG performance status of 0 or 1
- Measurable disease according to RECIST 1.1 criteria
- No prior immune-mediated therapy including anti-CTLA-4 or anti-PD-1 antibodies
- Adequate liver and kidney function within 14 days before registration
- Adequate bone marrow function within 14 days before registration
- Negative pregnancy test for women of reproductive potential within 21 days before enrollment
- Women of reproductive potential must use effective contraception for 23 weeks after last study drug dose
- Men sexually active with women of reproductive potential must use effective contraception for 31 weeks after last study drug dose
- Ability and willingness to provide informed consent
- Willingness and ability to comply with study protocol and visits
- Consent to use leftover tissue samples for research purposes
You will not qualify if you...
- Participation in another investigational study within 4 weeks before first treatment or unresolved previous adverse events
- History of invasive malignancy within 5 years or recent cancer treatments within 5 years prior to study day 0
- Major surgery for other reasons without adequate recovery before treatment
- Use of systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive medication within 14 days before day -5
- Active autoimmune disease requiring systemic steroids within past 3 months or history of severe autoimmune disease
- Active, known, or suspected autoimmune disease except certain controlled conditions
- Evidence of interstitial lung disease or active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Prior therapy with immune checkpoint inhibitors or drugs targeting T-cell costimulation
- History of allergic reactions to similar compounds or study agents
- Conditions, therapies, or lab abnormalities that may interfere with study participation or results
- Psychiatric or substance abuse disorders affecting study cooperation
- Pregnancy, breastfeeding, or planning conception during study through 23 weeks after last dose
- Known HIV infection
- Known active Hepatitis B or C infection
- History of active tuberculosis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
S
Song Fan, Doctor degrees
CONTACT
T
Tingting Cai, Bachelor's Degrees
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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