Head and Neck Squamous Cell Carcinoma, HNSCC
Conditions
Interventions
experimental group:Sintilimab Combined with Anlotinib and TP Regimen Chemotherapy
Sponsors
Mianyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1.Willing to participate in the clinical study and provide signed informed consent. 2.Age: 18–70 years, both male and female. 3.Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, larynx) that is not curable with local therapy. 4.ECOG PS score: 0–2. 5.Presence of measurable lesions according to RECIST criteria. 6.Expected survival = 12 weeks. 7.Patients must be able to swallow oral medications and have no significant gastrointestinal abnormalities that would impair absorption. 8.Normal cardiac and pulmonary function as assessed by the investigator. 9.No prior immunotherapy with PD-1 or PD-L1 inhibitors. 10.No prior anti-angiogenic targeted therapy. 11.No significant contraindications to chemotherapy, anti-angiogenic therapy, or immunotherapy. 12.Willing to use effective contraception during the study treatment period and for 120 days after the end of treatment. 13.Women of childbearing potential must have used reliable contraception, with a negative serum pregnancy test within 7 days prior to enrollment.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1.History of or concurrent other malignancies. 2.Unclear primary lesion. 3.Previous treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways. 4.Presence of severe active autoimmune disease requiring long-term corticosteroid or systemic immunosuppressive therapy. 5.Congenital or acquired immunodeficiency (e.g., HIV infection). 6.Pregnant or lactating women. 7.Severe cardiac or pulmonary disease. 8.Conditions such as dysphagia, chronic diarrhea, esophageal fistula, or intestinal obstruction that significantly affect drug administration and absorption. 9.Coagulation abnormalities or patients with a clear risk of gastrointestinal bleeding. 10.Participation in another drug clinical trial within 4 weeks prior to enrollment. 11.Any other severe physical or mental illness, or abnormal laboratory findings, that may increase the risk associated with study participation, affect protocol compliance, interfere with study results, or make the patient unsuitable for participation in the investigator’s judgment. 12.Other conditions considered by the physician as unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tumor lesion; | — |
Secondary
| Measure | Time frame |
|---|---|
| electrocardiogram;echocardiography; | — |
Countries
China
Contacts
Public ContactMiao Xiang
Mianyang Central Hospital
Outcome results
None listed