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

NCT04814069 | Unknown Phase 2

• 1 other identifier: 2021HNRT01
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate whether concurrent Tislelizumab with postoperative chemoradiotherapy would have survival benefit in high Risk HNSCC Patients.

Conditions

Head and Neck Cancer; Radiation; PD-1

Outcome Measures

Primary Outcomes (1)

• 1-year disease free survival

  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

  1 year

Secondary Outcomes (2)

• 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

Interventions

Tislelizumab DRUG

Tislelizumab 200mg q3w

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 24, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: December 31, 2023
• Last Updated: March 24, 2021

Record last verified: 2021-03