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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04814069
• Other study ID #: 2021HNRT01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2021
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: December 31, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma of the head and neck. Site of tumor origin in the oral cavity, oropharynx (p16-), larynx, or hypopharynx

2. With at least one high risk factor after radical surgery ?positive margin; ?close margin(<5mm); ?ENE.

3. No distant metastases

4. No synchronous or concurrent head and neck primary tumors

5. ECOG PS 0-1

6. 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 Criteria:

1. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region

2. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma

3. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures

4. Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

5. 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

6. Using systemic immunosuppressive agents and continue the dose within 2 weeks prior to the enrollment;

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• PD-1
• Radiation
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Tislelizumab
Tislelizumab 200mg q3w

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	from date of enrollment until death from any cause	2 years
Secondary	Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v4.0 during the course of treatment	Acute toxicity profiles, graded according to the NCI CTCAE version 4.0	up to 3 months after completion of radiotherapy