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

Launched by GUANGZHOU UNIVERSITY OF TRADITIONAL CHINESE MEDICINE · Sep 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CHG0521 oral coating for patients with a type of cancer known as squamous cell carcinoma of the tongue. This trial is designed for adults aged 18 to 80 who have been diagnosed with this specific type of cancer and are not suitable for surgery, have declined surgery, or have had their cancer return after previous treatments. To participate, patients must have at least one measurable tumor and normal functioning organs, among other criteria.

The trial is not yet recruiting participants, but once it starts, eligible patients can expect to receive the CHG0521 oral coating and will be monitored closely for its effects. It’s important to note that patients with certain health issues, allergies, or those currently involved in other clinical trials will not be able to participate. This study aims to gather more information on how effective the oral coating is for treating this type of cancer, helping to find better options for patients in the future.

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Eligibility criteria

• 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.
• • 3. 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.
• • 4. No concurrent use of other traditional Chinese medicine orally or externally within the past 3 months.
• • 5. 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.
• • 7. 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.