Actively Recruiting
PD-1 Inhibitor Therapy Versus Radiotherapy in pCR Patients With Locally Advanced HNSCC After Neoadjuvant Immunochemotherapy
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-08-08
324
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor
F
First People's Hospital of Foshan
Collaborating Sponsor
AI-Summary
What this Trial Is About
In patients with locally advanced head and neck squamous cell carcinoma undergoing standard surgical treatment after neoadjuvant immunochemotherapy, can PD-1 inhibitor therapy be used instead of adjuvant radiotherapy for both primary and lymph node pathology? To provide further evidence-based medical evidence for the late precision treatment of HNSCC patients after neoadjuvant immunochemotherapy. Avoid the side effects caused by excessive radiotherapy, especially avoid the occurrence of second primary cancer, radiation osteonecrosis and other diseases. 1. Main study endpoint: A randomized controlled, non-inferiority, multicentre Phase III trial was conducted to investigate the difference in 5-year overall survival (OS) between experimental group (Group B) and control group (group A) in patients undergoing standard surgical treatment after neoadjuvant immunochemotherapy for locally advanced HNSCC, with both primary and lymph node pathology revealed by pCR. At the same time, adverse events and safety were evaluated according to NCI-CTCAE 5.0 criteria and RTOG later radiotherapy damage evaluation criteria. Safety indicators focused on late radiotherapy toxicity and the incidence of grade 3 and 4 adverse reactions in NCI-CTC AE 5.0 and RTOG. The differences in the incidence of grade 3 and 4 adverse events were compared between the experimental group and the control group. 2. Secondary study endpoint: The differences in 2-year disease-free survival (DFS), regional relapse-free survival (RRFS), distant metastasis free survival (DMFS), safety and adverse events were compared. Safety evaluation NCI-CTC AE 5.0 standard was used to evaluate the acute safety index of radiotherapy, and RTOG late-stage damage evaluation standard was used to evaluate the late-stage safety index of radiotherapy. 4\) Exploratory goals The influence of prognostic laboratory indicators, clinical risk factors were analyzed. To explore the factors that influence the efficacy of radiotherapy after pCR immunotherapy.
CONDITIONS
Official Title
PD-1 Inhibitor Therapy Versus Radiotherapy in pCR Patients With Locally Advanced HNSCC After Neoadjuvant Immunochemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with locally advanced head and neck squamous cell carcinoma (AJCC 8th) treated with standard surgery after neoadjuvant immunochemotherapy showing complete pathological response in both primary and lymph node tissues.
- Locally advanced HNSCC includes T3 N0 M0; T1-T3 N1-N2 M0; or T4a N0-2 M0 stages.
- No history of other malignant tumors.
- Age between 18 and 65 years.
- Normal baseline lab values including neutrophil count ≥1.5x10^9/L without recent granulocyte stimulating factor, platelets ≥100x10^9/L without recent transfusion, hemoglobin ≥9 g/dL without recent transfusion or erythropoietin use.
- Total bilirubin ≤1.5 times upper limit of normal (ULN).
- AST and ALT ≤2.5 times ULN (≤5 times ULN if liver metastasis).
- Serum creatinine ≤1.5 times ULN and creatinine clearance ≥60 ml/min.
- Good coagulation function (INR or PT ≤1.5 times ULN).
- Normal thyroid function with TSH in normal range or normal total T3/FT3 and FT4 if TSH abnormal.
- Normal myocardial enzyme profile or judged clinically insignificant abnormalities.
- Negative pregnancy test for females of childbearing potential within 3 days before first drug administration.
- Use of effective contraception with less than 1% failure rate during treatment and up to 120 days after last study drug or 180 days after last chemotherapy.
- Signed informed consent form.
You will not qualify if you...
- HNSCC that is not the initial diagnosis or after neoadjuvant therapy for other malignant tumors.
- Active autoimmune disease requiring systemic therapy in past 2 years (except certain hormone therapies).
- History of allogeneic organ or stem cell transplantation (except corneal).
- HIV infection.
- Untreated active hepatitis B infection.
- Active hepatitis C infection.
- Pregnant or breastfeeding women.
- Serious or uncontrolled systemic diseases including severe ECG abnormalities, unstable angina, heart failure (NYHA grade ≥2), recent arterial thrombosis or embolism.
- Poorly controlled blood pressure (systolic >140 mmHg or diastolic >90 mmHg).
- Recent non-infectious pneumonia requiring steroids or active interstitial lung disease.
- Active pulmonary tuberculosis.
- Active or uncontrolled infections requiring systemic treatment.
- Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction.
- Liver diseases like cirrhosis or active hepatitis.
- Poorly controlled diabetes (fasting blood glucose >10 mmol/L).
- Significant proteinuria (≥++ on urine test and >1.0 g/24h).
- Mental disorders preventing study cooperation.
- Any other medical conditions or lab abnormalities that may interfere with study participation or safety as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun yat-sen memorial hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
J
Jinsong Li, MD
CONTACT
H
Haotian Cao, MD
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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