Actively Recruiting
De-escalation Radiation Strategy After NAC in Combination With ICI in LAHNSCC
Led by Ruijin Hospital · Updated on 2024-08-27
20
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm exploratory study conducted in LAHNSCC. Eligible patients received two cycles of pembrolizumab immunotherapy in combination with albumin-bound paclitaxel and cisplatin induction chemotherapy, followed by definitive concurrent radiochemotherapy. Three months after the completion of radiotherapy, a follow-up examination was conducted, and salvage surgery or systemic therapy was performed as necessary based on the follow-up results.
CONDITIONS
Official Title
De-escalation Radiation Strategy After NAC in Combination With ICI in LAHNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older with the ability to make medical decisions
- Signed informed consent form
- ECOG performance status of 0 or 1
- Diagnosed with oral, oropharyngeal, laryngeal, or hypopharyngeal cancer by pathology
- No distant metastasis present
- Measurable lesion according to RECIST 1.1 criteria
- Expected survival of at least 6 months
- Laboratory values within specified limits for blood counts, liver, kidney, thyroid, heart, and adrenal functions
- HBV-infected patients with HBV-DNA less than 500 IU/ml
- No history of other cancers in the past 5 years except basal cell skin cancer or thyroid cancer
You will not qualify if you...
- No indication for curative radiotherapy or contraindications to radiochemotherapy
- Clinical conditions such as bleeding, active infection, or mental factors that may affect study completion
- Need for long-term steroid therapy (oral or intravenous); local or inhaled steroids allowed
- Active autoimmune diseases or history of certain autoimmune diseases; corrected hypothyroidism and cortisol deficiency allowed
- History or evidence of active tuberculosis or non-infectious pneumonia
- Active viral hepatitis with HBV DNA over 500 IU/ml
- Acquired Immunodeficiency Syndrome (AIDS)
- Severe medical conditions affecting safety or study participation
- Prior immunotherapy for other cancers
- Other cancers diagnosed within 5 years except cured basal cell skin or thyroid cancer
- Pregnant or breastfeeding women
- Concurrent other malignant tumors
- Unable or unwilling to provide informed consent
- Vaccination within 4 weeks prior to study
- Allergic reactions to study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
Y
Yujie Wang, M.D.
CONTACT
Y
Yusheng Gao, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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