PD-1 Inhibitor Based Induction Chemotherapy Followed by De-escalation Protocols in OPSCC

Launched by FUDAN UNIVERSITY · Nov 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for oropharyngeal cancer, particularly focusing on patients who are either HPV-positive or HPV-negative. Researchers want to see if adding an immune therapy called Toripalimab to standard chemotherapy can help improve treatment responses. The goal is to find ways to reduce the amount of radiation therapy needed after the initial treatment while still maintaining good outcomes for patients.

To be eligible for this trial, participants must be at least 18 years old and have a specific type of oropharyngeal cancer confirmed through tests. They should not have received any previous cancer treatments and must be in fairly good health, with normal blood, liver, and kidney functions. Throughout the trial, participants will receive the combination of chemotherapy and the immune therapy, and their responses will be closely monitored. This study is currently recruiting participants, and it aims to find a more effective and less harmful way to treat oropharyngeal cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.
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