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

NCT04523883 | Unknown Phase 2 DMC

• 1 other identifier: 2020HNRT03
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

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

Keywords

Head and neck cancer; radiotherapy; PD-1

Outcome Measures

Primary Outcomes (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 Outcomes (3)

• 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

Study Arms (2)

concurrent PD-1

EXPERIMENTAL

Concurrent Immunotherapy With Postoperative Radiotherapy

Radiation: postoperative radiotherapy; Drug: JS001

Radiotherapy alone

ACTIVE COMPARATOR

Postoperative Radiotherapy alone

Radiation: postoperative radiotherapy

Interventions

postoperative radiotherapy RADIATION

postoperative radiotherapy with a dose of 60-66Gy

Radiotherapy alone; concurrent PD-1

JS001 DRUG

JS001 240mg every three week

Also known as: Toripalimab

concurrent PD-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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 5. No synchronous or concurrent head and neck primary tumors 6. ECOG PS 0-2 7. 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead
• Fudan University: collaborator
• Eye & ENT Hospital of Fudan University: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• First Affiliated Hospital of Fujian Medical University: collaborator
• Guizhou Provincial People's Hospital: collaborator
• Central South University: collaborator

Study Sites (1)

Guopei Zhu

Shanghai, 200011, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Central Study Contacts

Shengjin Dou

CONTACT

15800386875; doushengjin@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 24, 2020
• Study Start: August 10, 2020
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2024
• Last Updated: April 15, 2021

Record last verified: 2020-08

Locations

CN (1)