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

Sponsor
Ruijin Hospital
Study ID
NCT06572514
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatin — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 27, 2024
Start date
Oct 17, 2023
Status verified
Aug 2024
Primary completion
Sep 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: experimental arm
    Eligible patients received two cycles of pembrolizumab immunotherapy in combination with albumin-bound paclitaxel and cisplatin induction chemotherapy, followed by definitive concurrent radiochemotherapy.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 1 year ]

Central Contacts

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