Status:
RECRUITING
De-escalation Radiation Strategy After NAC in Combination With ICI in LAHNSCC
Lead Sponsor:
Ruijin Hospital
Conditions:
Locally Advanced Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 induc...
Eligibility Criteria
Inclusion
- ≥18 years old, with medical decision-making capacity
- Signed informed consent
- ECOG score of 0-1
- Pathologically diagnosed with oral cancer, oropharyngeal cancer, laryngeal cancer, or hypopharyngeal cancer
- Exclusion of distant metastasis
- Clearly evaluable lesion (per RECIST 1.1 criteria)
- Expected life span ≥6 months
- Laboratory test results meet the following requirements: WBC ≥ 3×10\^9/L, ANC ≥ 2.0×10\^9/L, PLT ≥ 80×10\^9/L, Hb ≥ 80g/L (according to the normal standards of the central laboratory); Liver function: Total bilirubin, ALT, and AST all ≤ 1.5x UNL (upper normal limit); AST (SGOT)/ALT (SGPT) ≤ 2.5 x IULN (upper normal limit); Kidney function: Cr ≤ 1.5x UNL (upper normal limit), and creatinine clearance rate ≥ 60 ml/min (calculated using the Cockcroft and Gault formula); Thyroid function T3 and T4 within the normal range (hypothyroidism can be corrected with oral thyroid hormone supplementation); Heart function: All three cardiac enzymes and pro-BNP within the normal range, no history of heart attack; Adrenal function: Normal cortisol secretion function or correctable based on endocrine assessment
- HBV-infected patients with HBV-DNA copy numbers less than 500 IU/ml
- No history of other malignant tumors in the past 5 years (excluding basal cell carcinoma of the skin and thyroid cancer).
Exclusion
- No indications for curative radiotherapy or contraindications to radiochemotherapy.
- Clinical factors identified by the investigator that could potentially affect the completion of the study protocol (such as bleeding, active infection, or mental factors).
- Patients requiring long-term maintenance steroid therapy (including oral and intravenous use); local use or inhalation can be included in the study.
- Previous history of autoimmune diseases or in the active phase of the disease \[including but not limited to inflammatory bowel disease (IBD), rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and its variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (such as Guillain-Barré syndrome)\], vitiligo, and correctable endocrine deficiencies such as hypothyroidism and physiological cortisol deficiency can be included in the study and are not exclusion criteria.
- History of active tuberculosis or non-infectious pneumonia or any clinical evidence.
- Active phase of viral hepatitis, HBV DNA \> 500 IU/ml.
- Acquired Immunodeficiency Syndrome (AIDS).
- Concurrent severe medical conditions (including heart diseases) with coexisting diseases or conditions affecting the patient's normal enrollment or safety during the study.
- Prior immunotherapy for other tumors.
- History of other malignant tumors within 5 years (excluding cured basal cell carcinoma of the skin or thyroid cancer).
- Pregnant or lactating women.
- Concurrently suffering from other malignant tumors.
- Cannot or unwilling to sign the informed consent form.
- Vaccination within 4 weeks.
- Allergic reaction to the investigational drug.
Key Trial Info
Start Date :
October 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06572514
Start Date
October 17 2023
End Date
April 1 2027
Last Update
August 27 2024
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025