De-escalation Radiation Strategy After NAC in Combination With ICI in LAHNSCC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
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
Qualifiers
≥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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatin
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
1Ruijin Hospital, Shanghai Jiaotong University School of Medicine200025, ShanghaiShanghai Municipality, China
Sponsors and collaborators
Ruijin Hospital
Lead sponsor
Source ClinicalTrials.gov