Concurrent Immunotherapy With Postoperative Radiotherapy in Intermediate/High Risk HNSCC Patients Unfit for Cisplatin: The IMPORT Study (IMPORT)

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

Sponsors

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

Collaborator: Fudan University
Eye & ENT Hospital of Fudan University
Tianjin Medical University Cancer Institute and Hospital
First Affiliated Hospital of Fujian Medical University
Guizhou Provincial People's Hospital
Central South University

Source Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Brief Summary

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

Overall Status Recruiting
Start Date 2020-08-10
Completion Date 2024-08-09
Primary Completion Date 2022-08-09
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Disease free survival from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
Secondary Outcome
Measure Time Frame
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
Enrollment 316
Condition
Intervention

Intervention Type: Radiation

Intervention Name: postoperative radiotherapy

Description: postoperative radiotherapy with a dose of 60-66Gy

Intervention Type: Drug

Intervention Name: JS001

Description: JS001 240mg every three week

Arm Group Label: concurrent PD-1

Other Name: Toripalimab

Eligibility

Criteria:

Inclusion Criteria: - 1. 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) 2. 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. 3. 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. 4. No distant metastases 5. No synchronous or concurrent head and neck primary tumors 6. ECOG PS 0-2 7. Adequate organ function including the following: 1. Absolute neutrophil count (ANC) >= 1.5 * 10^9/l 2. Platelets count >= 80 * 10^9/l 3. Hemoglobin >= 80 g/dl 4. AST and ALT <= 2.5 times institutional upper limit of normal (ULN) 5. Total bilirubin <= 1.5 times institutional ULN 6. 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;

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Shengjin Dou

Phone: 15800386875

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Guopei Zhu Shengjin Dou 15800386875 [email protected] Guopei Zhu Principal Investigator
Location Countries

China

Verification Date

2020-08-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: concurrent PD-1

Type: Experimental

Description: Concurrent Immunotherapy With Postoperative Radiotherapy

Label: Radiotherapy alone

Type: Active Comparator

Description: Postoperative Radiotherapy alone

Acronym IMPORT
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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