Actively Recruiting
Postoperative CCRT Followed by Immunotherapy in High-Risk LA HNSCC
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2023-12-14
173
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial aims to evaluate whether the addition of anti-PD-1 antibody to adjuvant postoperative chemoradiotherapy could improve disease free survival in patients with high-risk locally advanced head and neck squamous cell carcinoma (HNSCC).
CONDITIONS
Official Title
Postoperative CCRT Followed by Immunotherapy in High-Risk LA HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed squamous cell carcinoma of the head and neck, including oral cavity, oropharynx, hypopharynx, or larynx
- Presence of one or more high-risk factors such as T4 tumor, cN3 or pN2 lymph nodes, non-R0 resection, resection margin less than 5mm, extranodal extension, perineural invasion, vessel or lymphatic invasion, or specific cervical lymph node metastases
- ECOG performance score of 0 or 1
- PD-L1 expression with combined positive score greater than 1
- No contraindications to immunotherapy or chemoradiotherapy
- Adequate organ function
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before first dose and agree to use effective contraception during and for 60 days after treatment
- Male participants must agree to use effective contraception during and for 60 days after treatment
- Ability to provide informed consent
You will not qualify if you...
- Previous or co-existing cancers except cured basal cell carcinoma of the skin, cervical carcinoma in situ, or superficial bladder cancer
- Active infection
- Known active viral infections such as HIV or Hepatitis B/C, or history of positive HIV test
- Active or historical autoimmune diseases except resolved vitiligo or childhood asthma
- Significant active cardiovascular disease including recent stroke or heart attack within 6 months, unstable angina, congestive heart failure class II or higher, or serious arrhythmia requiring medication
- Pregnant or breastfeeding individuals or those unwilling or unable to use two effective contraception methods during the study
- Prior treatment with PD-1 or PD-L1 inhibitors
- Major surgery for non-tumor conditions with unresolved toxicity or complications
- Participation in another experimental cancer treatment trial within 28 days before starting this study
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cancer Cencer/Cancer hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
J
Jingbo Wang, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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