Status:
UNKNOWN
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
Lead Sponsor:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions:
Head and Neck Cancer
Radiation
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
To investigate whether concurrent Tislelizumab with postoperative chemoradiotherapy would have survival benefit in high Risk HNSCC Patients.
Eligibility Criteria
Inclusion
- 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 8. Signed written informed consent
Exclusion
- 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;
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04814069
Start Date
April 1 2021
End Date
December 31 2023
Last Update
March 24 2021
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