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

Phase 2

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Radiation: postoperative radiotherapy; Drug: JS001

• Registration Number: NCT04523883
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-08-10
• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-21
• Study First Posted: 2020-08-24
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-15
• Primary Completion: 2022-08-09
• Study Completion: 2024-08-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 316

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.

  2. 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:
  5. Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
  6. Platelets count >= 80 * 10^9/l
  7. Hemoglobin >= 80 g/dl
  8. AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
  9. Total bilirubin <= 1.5 times institutional ULN
  10. 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
concurrent PD-1	postoperative radiotherapy	Concurrent Immunotherapy With Postoperative Radiotherapy
concurrent PD-1	JS001	Concurrent Immunotherapy With Postoperative Radiotherapy
Radiotherapy alone	postoperative radiotherapy	Postoperative Radiotherapy alone

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Guopei Zhu; 🇨🇳 Shanghai, China