Actively Recruiting
The Efficacy and Safety of Neoadjuvant Low-dose Radiotherapy Combined With Chemoimmunotherapy in Locally Advanced HNSCC
Led by Fifth Affiliated Hospital, Sun Yat-Sen University · Updated on 2022-12-29
25
Participants Needed
2
Research Sites
264 weeks
Total Duration
On this page
Sponsors
F
Fifth Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor
D
Dongguan People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of neoadjuvant low-dose radiotherapy combined with chemoimmunotherapy in resectable locally advanced head and neck squamous cell carcinoma. The eligible patients are scheduled to administered neoadjuvant low-dose radiotherapy, tislelizumab, combined with albumin-bound paclitaxel and cisplatin for two cycles. Radical resection will be performed in 3-4 weeks after two cycles of neoadjuvant therapy. The overall primary study hypothesis is that the novel neoadjuvant combination regime improves the pathological complete response (pCR) rate, with tolerable side effects.
CONDITIONS
Official Title
The Efficacy and Safety of Neoadjuvant Low-dose Radiotherapy Combined With Chemoimmunotherapy in Locally Advanced HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Untreated, confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, or larynx) staged T3-4N0M0 or T1-4N1-3M0, III-IVB by AJCC 8th edition
- Eligible for radical surgery as judged by surgeons
- Aged 18 to 70 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Life expectancy over 6 months
- At least one measurable tumor lesion according to RECIST 1.1
- Adequate organ function meeting specified blood counts, liver, kidney, clotting, and thyroid hormone levels
- Women of childbearing age must agree to use contraception during treatment and for 3 months after
- Voluntary participation with signed informed consent and good compliance
You will not qualify if you...
- Pregnant or breastfeeding women
- History of allergy to PD-1 inhibitors, albumin-bound paclitaxel, or cisplatin
- History of other malignancies within 5 years except cured basal cell carcinoma, cervical in situ cancer, or thyroid papilloma
- Uncontrolled heart conditions including NYHA class II or higher heart failure, unstable angina, recent myocardial infarction, or serious arrhythmias
- Prior use of investigational drugs or concurrent participation in other clinical trials except observational studies
- Recent systemic corticosteroid or immunosuppressant use above specified doses
- Live vaccines within 4 weeks before study drug
- Major surgery or severe trauma within 4 weeks before study drug
- Serious infections requiring hospitalization within 4 weeks or active lung inflammation needing antibiotics
- Active autoimmune diseases or syndromes except certain stable conditions
- Immunodeficiency including HIV or history of organ or bone marrow transplant
- Active or recent tuberculosis infection
- Active hepatitis B or C infection
- History of substance abuse including psychotropic drugs or alcoholism
- Any other condition judged by researchers as unsuitable for participation
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China, 519000
Actively Recruiting
2
Zhigang Liu
Dongguan, China, 523059
Actively Recruiting
Research Team
Z
Zhigang Liu, Dr.
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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