CHG0521 Oral Coating in Patients with Solid Tissue Tumor/Recurrent/Metastatic TSCC

Inclusion criteria

• 1. Age range: 18-80 years, encompassing both males and females. 2. Confirmation of tongue squamous cell carcinoma through histopathology or cytology is required.

• Patients who are deemed unsuitable for surgery, have surgical indications but decline the treatment, or experience relapse and metastasis after surgery with no further surgical options available.

• No concurrent use of other traditional Chinese medicine orally or externally within the past 3 months.

• Presence of at least one measurable lesion according to RECIST 1.1 criteria. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

• Expected survival time should be equal to or greater than 3 months. 8. Liver function indicators: total bilirubin level ≤1.5 times the upper limit of normal (ULN), AST and ALT levels ≤2.5 times ULN (or ≤5 times ULN in case of liver metastasis).

9.Renal function indicators: serum creatinine (CRE) ≤1.5×ULN and calculated creatinine clearance (using Cockcroft-Gault formula) ≥60 ml/min.

10.The functionality of vital organs should be essentially normal.

Exclusion criteria

• 1. Patients with tongue squamous cell carcinoma who have undergone tumor resection without any residual tumor; 2. Patients with a known allergy to any therapeutic ingredient or a history of hypersensitivity or allergic constitution; 3. Patients who have experienced a severe infection within 4 weeks prior to the first use of the investigational drug, and whose common adverse reaction criteria were graded as >2; 4. Patients with a history of immune deficiency, organ transplantation, or allogeneic bone marrow transplantation; 5. Patients currently enrolled in another concurrent clinical study; 6. Pregnant and lactating women.