Status:
UNKNOWN
Concurrent Immunotherapy With Postoperative Radiotherapy in Intermediate/High Risk HNSCC Patients Unfit for Cisplatin: The IMPORT Study (IMPORT)
Lead Sponsor:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborating Sponsors:
Fudan University
Eye & ENT Hospital of Fudan University
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
- 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:
- 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
Exclusion
- 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;
Key Trial Info
Start Date :
August 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 9 2024
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT04523883
Start Date
August 10 2020
End Date
August 9 2024
Last Update
April 15 2021
Active Locations (1)
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1
Guopei Zhu
Shanghai, China, 200011