Actively Recruiting
A Study of Toripalimab as Consolidation Therapy After Postoperative Chemoradiotherapy in HNSCC
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-04-14
41
Participants Needed
2
Research Sites
305 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a phase II, open label, single-arm and exploratory clinical trial. The purpose of this study is to observe the efficacy and safety of consolidation immunotherapy with Toripalimab following postoperative radiotherapy or chemoradiotherapy for patients with locally advanced head and neck squamous cell carcinomas (HNSCC).
CONDITIONS
Official Title
A Study of Toripalimab as Consolidation Therapy After Postoperative Chemoradiotherapy in HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postoperative patients with adverse prognostic factors in locally advanced head and neck squamous cell carcinoma
- Completed postoperative adjuvant radiotherapy or chemoradiotherapy within the last 2 months
- Age 18 years or older and under 70 years at study entry
- ECOG performance status of 0 or 1
- Measurable disease according to RECIST 1.1 criteria
- Adequate liver and kidney function with serum creatinine < 1.5 times upper limit of normal or creatinine clearance > 40 mL/min
- AST/ALT levels less than or equal to 3 times upper limit of normal
- Total bilirubin less than or equal to 1.5 times upper limit of normal (up to 3.0 mg/dL if Gilbert Syndrome present)
- Adequate bone marrow function with neutrophils > 1,500/µL, platelets > 100,000/µL, and hemoglobin > 9.0 g/dL
- Women of reproductive potential must have a negative pregnancy test within 7 days before enrollment
- Women of reproductive potential must use highly effective contraception during the study and for 3 months after last dose
- Men sexually active with women of reproductive potential must use contraception during the study and for 3 months after last dose unless azoospermic
- Able to understand and willing to sign informed consent
- Willing and able to comply with study procedures and visits
You will not qualify if you...
- Participation in another investigational drug study within 4 weeks before starting treatment or ongoing adverse events from prior studies
- History of another invasive cancer within 5 years, except certain cured skin, cervical, or thyroid cancers
- Recent major surgery with unresolved toxicity or complications
- Active or suspected autoimmune disease
- Evidence of interstitial lung disease or active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Previous treatment with anti-PD-1 antibody
- History of allergic reactions to related compounds
- Known psychiatric or substance abuse disorders affecting study cooperation
- Pregnancy, breastfeeding, or planning conception during study and up to 23 weeks after last dose
- Known HIV infection
- Active Hepatitis B or C infection
- History of active tuberculosis
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
2
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
Research Team
S
Song Fan, Doctor degrees
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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