A Clinical Trial Comparing the Efficacy and Safety of Anyouping® and Platinum-based Chemotherapy With Enlituo® in Advanced Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
This study is a Phase II/III clinical trial, aimed to evaluate the efficacy and safety of Enlituo® combined with Anyouping® plus platinum and nab-paclitaxel chemotherapy as first-line therapy for advanced, recurrent or metastatic HNSCC. Phase II Part Approximately 60 participants will be enrolled and randomly assigned at a 1:1 ratio to the experimental group. Phase III Part Approximately 302 participants will be enrolled and randomly assigned in a 1:1 double-blind manner to the experimental group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
362
Enlituo®:Enlituo® is administered according to the protocol. Anyouping®:Anyouping® is administered according to the protocol. Platinum-based chemotherapy (PBC):Cisplatin (DDP) or Carboplatin (CBP) plus Albumin-bound Paclitaxel (nab-paclitaxel) are administered according to the protocol.
Comparator in Phase 2 is Anyouping® + PBC. Comparator in Phase 3 is Placebo-Enlituo + Anyouping® + PBC. Placebo-Enlituo (only in Phase 3):Placebo-Enlituo is administered according to the protocol. Anyouping®:Anyouping® is administered according to the protocol. Platinum-based chemotherapy (PBC):Cisplatin (DDP) or Carboplatin (CBP) plus Albumin-bound Paclitaxel (nab-paclitaxel) are administered according to the protocol.
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Overall Survival (Phase 3)
Time frame: Up to 2 years.
Objective Response Rate (Phase 2)
Time frame: Up to 2 years.
Duration of response
The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated,respectively in Phase 3.
Time frame: Up to 2 years.
Disease control rate
The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated,respectively in Phase 3.
Time frame: Up to 2 years.
Progression-Free Survival
The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated,respectively in Phase 3.
Time frame: Up to 2 years.
Objective Response Rate (Phase 3)
The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated,respectively.
Time frame: Up to 2 years.
Overall Survival (Phase 2)
Time frame: Up to 2 years.
Time to Progression
The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated,respectively in Phase 3.
Time frame: Up to 2 years.
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE V6.0. Incidence of AE leading to dose interruption, dose delay and treatment discontinuation.
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Time frame: From the date of informed consent signature until 28 days after the last dose (each cycle is 21 days, up to 35 cycles or 2 years).