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

NCT ID: NCT04523883

Last Updated: 2021-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-10
• Study Completion Date: 2024-08-09

Brief Summary

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

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

concurrent PD-1

Concurrent Immunotherapy With Postoperative Radiotherapy

Group Type: EXPERIMENTAL

postoperative radiotherapy

Intervention Type: RADIATION

postoperative radiotherapy with a dose of 60-66Gy

JS001

Intervention Type: DRUG

JS001 240mg every three week

Radiotherapy alone

Postoperative Radiotherapy alone

Group Type: ACTIVE_COMPARATOR

postoperative radiotherapy

Intervention Type: RADIATION

postoperative radiotherapy with a dose of 60-66Gy

Interventions

postoperative radiotherapy

postoperative radiotherapy with a dose of 60-66Gy

Intervention Type: RADIATION

JS001

JS001 240mg every three week

Intervention Type: DRUG

Other Intervention Names

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: collaborator

Guizhou Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Central South University

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guopei Zhu

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Shengjin Dou

Role: CONTACT

doushengjin@126.com

15800386875

Facility Contacts

Shengjin Dou

Role: primary

doushengjin@126.com

15800386875

Other Identifiers

2020HNRT03

Identifier Type: -

Identifier Source: org_study_id