Randomized Phase II Trial of Postoperative Radiotherapy With Concurrent JS001（PD-1 Antibody） vs. Postoperative Radiotherapy Alone in Intermediate/High-risk Head and Neck Cancer Patients With a Contraindication to Cisplatin

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 site in 1 country316 target enrollmentAugust 10, 2020

ConditionsHead and Neck Squamous Cell Carcinoma

Interventionspostoperative radiotherapy JS001

DrugsJS001

Overview

Phase: Phase 2
Intervention: postoperative radiotherapy
Conditions: Head and Neck Squamous Cell Carcinoma
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Enrollment: 316
Locations: 1
Primary Endpoint: Disease free survival
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To investigate weather concurrent JS001 with postoperative radiotherapy would have survival benefit in intermediate/high Risk HNSCC Patients who cannot take cisplatin

Registry

clinicaltrials.gov

Start Date

August 10, 2020

End Date

August 9, 2024

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, hypopharynx , or sinuses (excluding nasopharynx)
•With at least one risk factors after radical surgery ①positive margin; ②close margin（\<5mm); ③ENE;④PNI;⑤LVI; ⑤ pT3-4/N2-3( AJCC 8th).⑥ Level IV/V lymph node metastases for OPC or OC.
•Have at least one contraindication to cisplatin as defined:
•① Age\>65 years old; ②Creatinine clearance (CC) \> 30 and \< 60 cc/min For this calculation, use the Cockroft-Gault formula: CC = 0.85 (if female)\* ((140-Age) / (Serum Creatinine)) \* (Weight in kg / 72); ③ Zubrod performance status 2; ④Pre-existing peripheral neuropathy grade ≥ 1; ⑤History of hearing loss, defined as either: ▪ Existing need of a hearing aid OR ≥ 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated.
•No distant metastases
•No synchronous or concurrent head and neck primary tumors
•ECOG PS 0-2
•Adequate organ function including the following:
•Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l
•Platelets count \>= 80 \* 10\^9/l

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;

Arms & Interventions

concurrent PD-1

Concurrent Immunotherapy With Postoperative Radiotherapy

Intervention: postoperative radiotherapy

concurrent PD-1

Concurrent Immunotherapy With Postoperative Radiotherapy

Intervention: JS001

Radiotherapy alone

Postoperative Radiotherapy alone

Intervention: postoperative radiotherapy

Outcomes

Primary Outcomes

Disease free survival

Time Frame: from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years

Secondary Outcomes

Overall survival(from date of enrollment until death from any cause, assessed up to 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)
Number of participants with treatment-related late toxicity as assessed by CTCAE v4.0(from 3 months after completion of radiotherapy up to 2 years)