Status:
NOT_YET_RECRUITING
CHG0521 Oral Coating in Patients with Solid Tissue Tumor/Recurrent/Metastatic TSCC
Lead Sponsor:
Guangzhou University of Traditional Chinese Medicine
Conditions:
Squamous Cell Carcinoma
Squamous Cell Carcinoma of the Oral Cavity
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a prospective single-arm loading test study of CHG0521 oral coating in patients with solid tissue tumor/recurrent/metastatic TSCC
Eligibility Criteria
Inclusion
- 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).
- Renal function indicators: serum creatinine (CRE) ≤1.5×ULN and calculated creatinine clearance (using Cockcroft-Gault formula) ≥60 ml/min.
- The functionality of vital organs should be essentially normal.
Exclusion
- 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.
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06609070
Start Date
October 15 2024
End Date
August 31 2026
Last Update
September 23 2024
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