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

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 2

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Drug: JS001; Radiation: postoperative radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04523883

2020HNRT03

Details and patient eligibility

About

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

Enrollment: 316 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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316 participants in 2 patient groups

concurrent PD-1

Experimental group

Description:

Concurrent Immunotherapy With Postoperative Radiotherapy

Treatment:

Drug: JS001

Radiation: postoperative radiotherapy

Radiotherapy alone

Active Comparator group

Description:

Postoperative Radiotherapy alone

Treatment:

Radiation: postoperative radiotherapy