Clinical trial NCT04523883: Concurrent Immunotherapy With Postoperative Radiotherapy in Intermediate/High Risk HNSCC Patients Unfit for Cisplatin: The IMPORT Study (IMPORT)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Head and neck cancer
radiotherapy
PD-1
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
Collaborators: name: Fudan University
name: Eye & ENT Hospital of Fudan University
name: Tianjin Medical University Cancer Institute and Hospital
name: First Affiliated Hospital of Fujian Medical University
name: Guizhou Provincial People's Hospital
name: Central South University
First posted: 2020-08-24
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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;

Primary outcomes:
measure: Disease free survival
timeFrame: from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: from date of enrollment until death from any cause, assessed up to 2 years
measure: Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v4.0 during the course of treatment
timeFrame: up to 3 months after completion of radiotherapy
measure: Number of participants with treatment-related late toxicity as assessed by CTCAE v4.0
timeFrame: from 3 months after completion of radiotherapy up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Guopei Zhu
Study officials:
References: