Actively Recruiting
Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-04-03
133
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients.
CONDITIONS
Official Title
Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with head and neck squamous cell carcinoma who have undergone 2 to 4 cycles of induction chemotherapy and immunotherapy and plan to receive radical radiotherapy
- Age between 18 and 75 years
- Diagnosis confirmed by pathological tissue biopsy
- Clinical staging T1-2N2-3M0 or T3-4N0-3M0 according to AJCC 8th edition
- Negative for HPV or P16
- ECOG performance status of 0 or 1
- No contraindications to immunotherapy and radiotherapy
- Adequate blood counts and organ function as specified (WBC, ANC, PLT, HGB, liver and kidney function, coagulation, myocardial enzymes)
- Women of childbearing age must use reliable contraception or have a negative pregnancy test within 7 days before enrollment; men with partners of childbearing potential must use contraception during and 2 months after treatment
- Willing to participate voluntarily, sign informed consent, comply with study procedures and follow-up
You will not qualify if you...
- Previous or concurrent incurable malignant tumors except certain cured cancers
- Active autoimmune diseases or history of autoimmune diseases (with some exceptions)
- Uncontrolled cardiovascular diseases or recent myocardial infarction
- Active infection or unexplained fever above 38.5°C during screening or before first treatment
- Congenital or acquired immune deficiency, active hepatitis B or C infection
- Prior treatment with PD-1 or PD-L1 antibodies
- Known allergies to cisplatin, protein preparations, or PD-1 antibody components
- Recent major surgery without full recovery
- Pregnant or breastfeeding women
- Other serious medical or psychiatric conditions that may affect safety or study compliance according to investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
Beijing, China
Actively Recruiting
Research Team
Y
Yang Meng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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