NCT06572514 De-escalation Radiation Strategy After NAC in Combination With ICI in LAHNSCC
| NCT ID | NCT06572514 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Ruijin Hospital |
| Condition | Locally Advanced Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-10-17 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-10-17 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06572514 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06572514 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06572514 currently recruiting?
Yes, NCT06572514 is actively recruiting participants. Contact the research team at wyj12054@rjh.com.cn for enrollment information.
Where is the NCT06572514 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06572514 clinical trial?
NCT06572514 is sponsored by Ruijin Hospital. The trial plans to enroll 20 participants.