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.
Voluntarily sign the written informed consent form and be willing to comply with all requirements specified in the study protocol;
Aged ≥ 18 years;
Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (including oral cavity, oropharynx, hypopharynx, larynx), deemed incurable after local therapy;
Have not received any systemic therapy for recurrent or metastatic disease. Note: If disease progression occurs during neoadjuvant/adjuvant therapy, concurrent radiotherapy, or within 6 months after treatment discontinuation, the anti-tumor therapy administered during neoadjuvant/adjuvant therapy or concurrent radiotherapy (including platinum-based chemotherapy, anti-EGFR monoclonal antibodies, PD-1/PD-L1 inhibitors, etc.) will be regarded as first-line systemic therapy, and such subjects will be excluded.
Primary tumor site (any histologic type) located in nasopharynx, nasal cavity, paranasal sinus, salivary gland, thyroid or parathyroid gland, skin, or unknown primary origin;
Participants who have been diagnosed with a malignancy other than squamous cell carcinoma of the head and neck within 3 years prior to enrollment. Exceptions include cured basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or carcinoma in situ of the cervix and/or breast cancer treated with curative resection;
Participants with an expected survival of less than 6 months and/or rapidly progressive disease (e.g., participants experiencing rapid disease progression within 1-2 months during therapy planned prior to enrollment);
Participants eligible for curative-intent local therapy;
Parallel
Enlituo® + Anyouping® + PBC
DrugEnlituo®：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.
Placebo-Enlituo + Anyouping® + PBC
DrugComparator 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.
Overall Survival (Phase 3)
Objective Response Rate (Phase 2)
Duration of response
The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated，respectively in Phase 3.
Disease control rate
The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated，respectively in Phase 3.
Progression-Free Survival
The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated，respectively in Phase 3.
Objective Response Rate (Phase 3)
The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated，respectively.
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