De-escalation Radiation Strategy After NAC in Combination With ICI in LAHNSCC

Trial Title: De-escalation Radiation Strategy After NAC in Combination With ICI in LAHNSCC

NCT ID: NCT06572514

Condition: Locally Advanced Head and Neck Squamous Cell Carcinoma

Conditions: Official terms:
Squamous Cell Carcinoma of Head and Neck
Paclitaxel
Pembrolizumab
Albumin-Bound Paclitaxel

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatin
Description: The immunotherapy drug was pembrolizumab at a dose of 200 mg, administered on the first day of each cycle every 3 weeks. The induction chemotherapy regimen included albumin-bound paclitaxel at 260 mg/m2 and cisplatin at 75 mg/m2, given every 3 weeks, either concurrently with immunotherapy or on the second day.
Arm group label: experimental arm

Other name: definitive radiation

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 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. ≥18 years old, with medical decision-making capacity 2. Signed informed consent 3. ECOG score of 0-1 4. Pathologically diagnosed with oral cancer, oropharyngeal cancer, laryngeal cancer, or hypopharyngeal cancer 5. Exclusion of distant metastasis 6. Clearly evaluable lesion (per RECIST 1.1 criteria) 7. Expected life span ≥6 months 8. 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 9. HBV-infected patients with HBV-DNA copy numbers less than 500 IU/ml 10. No history of other malignant tumors in the past 5 years (excluding basal cell carcinoma of the skin and thyroid cancer). Exclusion Criteria: 1. No indications for curative radiotherapy or contraindications to radiochemotherapy. 2. Clinical factors identified by the investigator that could potentially affect the completion of the study protocol (such as bleeding, active infection, or mental factors). 3. Patients requiring long-term maintenance steroid therapy (including oral and intravenous use); local use or inhalation can be included in the study. 4. 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. 5. History of active tuberculosis or non-infectious pneumonia or any clinical evidence. 6. Active phase of viral hepatitis, HBV DNA > 500 IU/ml. 7. Acquired Immunodeficiency Syndrome (AIDS). 8. Concurrent severe medical conditions (including heart diseases) with coexisting diseases or conditions affecting the patient's normal enrollment or safety during the study. 9. Prior immunotherapy for other tumors. 10. History of other malignant tumors within 5 years (excluding cured basal cell carcinoma of the skin or thyroid cancer). 11. Pregnant or lactating women. 12. Concurrently suffering from other malignant tumors. 13. Cannot or unwilling to sign the informed consent form. 14. Vaccination within 4 weeks. 15. Allergic reaction to the investigational drug.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Address:
City: Shanghai
Zip: 200025
Country: China

Status: Recruiting

Contact:
Last name: Yunsheng Gao, M.D.

Phone: +86-021-64370045

Phone ext: 602400
Email: gys11856@rjh.com.cn

Start date: October 17, 2023

Completion date: April 2027

Lead sponsor:
Agency: Ruijin Hospital
Agency class: Other

Source: Ruijin Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06572514