NCT04814069UnknownPhase 2
A Multicenter Phase II Trial of Post-operative Concurrent Chemoradiotherapy Using Weekly Cisplatin With Tislelizumab for Patients With High-risk Head and Neck Squamous Cell Carcinoma：The POTENTIAL Study
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University0 sites38 target enrollmentStarted: April 1, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 38
- Primary Endpoint
- 1-year disease free survival
Study Overview
Brief Summary
To investigate whether concurrent Tislelizumab with postoperative chemoradiotherapy would have survival benefit in high Risk HNSCC Patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed squamous cell carcinoma of the head and neck. Site of tumor origin in the oral cavity, oropharynx (p16-), larynx, or hypopharynx
- •With at least one high risk factor after radical surgery ①positive margin; ②close margin（<5mm); ③ENE.
- •No distant metastases
- •No synchronous or concurrent head and neck primary tumors
- •ECOG PS 0-1
- •Adequate organ function including the following:
- •Absolute neutrophil count (ANC) >= 1.5 * 10^9/l Platelets count >= 80 * 10^9/l Hemoglobin >= 80 g/dl AST and ALT <= 2.5 times institutional upper limit of normal (ULN) Total bilirubin <= 1.5 times institutional ULN Creatinine clearance >30 ml/min
- •Signed written informed consent
Exclusion Criteria
- •Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
- •Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
- •Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
- •Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- •Active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment
- •Using systemic immunosuppressive agents and continue the dose within 2 weeks prior to the enrollment;
Outcomes
Primary Outcomes
1-year disease free survival
Time Frame: 1 year
from date of enrollment until date of first documented disease progression or from date of enrollment until date of first documented disease progression or death from any cause
Secondary Outcomes
- Overall survival(2 years)
- Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v4.0 during the course of treatment(up to 3 months after completion of radiotherapy)
Investigators
Guopei Zhu
Dr.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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