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

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04523883
• Collaborator: Fudan University (Other), Eye & ENT Hospital of Fudan University (Other), Tianjin Medical University Cancer Institute and Hospital (Other), First Affiliated Hospital of Fujian Medical University (Other), Guizhou Provincial People's Hospital (Other), Central South University (Other)
• Enrollment: 316
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Squamous Cell Carcinoma	Radiation: postoperative radiotherapy; Drug: JS001	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 316 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Aug 10, 2020
• Anticipated Primary Completion Date: Aug 9, 2022
• Anticipated Study Completion Date: Aug 9, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: concurrent PD-1 Concurrent Immunotherapy With Postoperative Radiotherapy	Radiation: postoperative radiotherapy; postoperative radiotherapy with a dose of 60-66Gy; Drug: JS001; JS001 240mg every three week; Other Names: Toripalimab
Active Comparator: Radiotherapy alone Postoperative Radiotherapy alone	Radiation: postoperative radiotherapy; postoperative radiotherapy with a dose of 60-66Gy

Outcome Measures

Primary Outcome Measures

1. 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 Measures

1. Overall survival [from date of enrollment until death from any cause, assessed up to 2 years]

2. 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]

   Acute toxicity profiles, graded according to the NCI CTCAE version 4.0

3. 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]

   Late toxicity profiles, graded according to the NCI CTCAE version 4.0

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. 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.

1. No distant metastases 5. No synchronous or concurrent head and neck primary tumors

2. ECOG PS 0-2 7. Adequate organ function including the following:

3. Absolute neutrophil count (ANC) >= 1.5 * 10^9/l

4. Platelets count >= 80 * 10^9/l

5. Hemoglobin >= 80 g/dl

6. AST and ALT <= 2.5 times institutional upper limit of normal (ULN)

7. Total bilirubin <= 1.5 times institutional ULN

8. 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guopei Zhu	Shanghai		China	200011

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• ClinicalTrials.gov Identifier: NCT04523883
• Other Study ID Numbers: 2020HNRT03
• First Posted: Aug 24, 2020
• Last Update Posted: Apr 15, 2021
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: Head and neck cancer; radiotherapy; PD-1
• Additional relevant MeSH terms: Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Apr 15, 2021