Status:
UNKNOWN
PD-1 Inhibitor Based Induction Chemotherapy Followed by De-escalation Protocols in OPSCC
Lead Sponsor:
Fudan University
Conditions:
Oropharyngeal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
More and more studies have shown that the efficacy and prognosis of HPV （Human papillomavirus）-positive oropharyngeal cancer (OPC) patients are better than those of others. However, in the NCCN (Natio...
Eligibility Criteria
Inclusion
- Histological diagnosis of squamous cell carcinoma of oropharynx; IHC p16 positive or PCR HPV16 positive; IHC p16 negative or PCR HPV16 negative; T3-4N0-3M0 or T1-2N2-3M0 according to UICC/AJCC 8th staging system; Age ≥18; No prior anti-tumor treatment; Informed consent obtained; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Normal complete blood count; Normal hepatic function; Normal renal function (creatinine ≤ 1.5 times the upper limit of normal). -
Exclusion
- Previous radiotherapy; A history of any other type of malignancy; Pregnancy or lactation; Obvious disfunction of liver, renal, cardiac or lung function; Un controlled infection; Systemic metastasis or distant metastasis; Patients with severe gastrointestinal diseases; Patients with mental disorders affecting patient participation in trial judgement.
- \-
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06156891
Start Date
June 29 2022
End Date
July 30 2025
Last Update
December 5 2023
Active Locations (1)
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1
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200032