This study is a single-arm Phase II trial designed to evaluate the efficacy and safety of Docetaxel, Nimotuzumab, and Pucotenlimab combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma who have failed prior PD-1/PD-L1 inhibitor and platinum-based therapies, for second-line and later-line treatment.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, with no deterioration within 2 weeks prior to enrollment.
Age ≥ 18 years and ≤ 75 years
Patients with pathologically and/or radiologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (including oral cavity, oropharynx, hypopharynx and larynx), who have previously failed treatment with PD-1 (L1) inhibitors and platinum-based drugs. The two types of drugs could be administered as a first-line combination regimen or sequential therapy, with the number of prior treatment lines not exceeding two. If disease progression occurs during neoadjuvant therapy, concurrent chemoradiotherapy or adjuvant therapy, or within 6 months after the discontinuation of such treatment, the medications used during neoadjuvant therapy, concurrent chemoradiotherapy or adjuvant therapy (including platinum-based drugs, anti-EGFR monoclonal antibodies, PD-1 (L1) inhibitors, etc.) shall be regarded as first-line treatment. Discontinuation or dose reduction of one drug during treatment, or replacement of platinum-based drugs, fluorouracil-based drugs or PD-1 (L1) inhibitors without disease progression shall be counted as the same line of treatment.
At least one radiologically measurable lesion according to RECIST v1.1
A history of malignant tumor is known.
Residual toxic reactions caused by prior anti-tumor therapy (including immunotherapy, targeted therapy, chemotherapy, radiotherapy, etc.) (excluding alopecia, fatigue and grade 2 hypothyroidism), or clinically significant laboratory test abnormalities > grade 1 (CTCAE v5.0)
Known to have active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate in the study, provided that their disease is stable.
A history of severe hypersensitivity reactions to taxanes or other monoclonal antibodies.
Sun Yat-sen University
Lead sponsor
Biotech Pharmaceutical Co., Ltd.
Collaborator
Lepu Biopharma Co., Ltd.
Collaborator