Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Oral Cavity
Conditions
Brief summary
This is a prospective single-arm loading test study of CHG0521 oral coating in patients with solid tissue tumor/recurrent/metastatic TSCC
Interventions
DRUGCHG0521 Oral Coating
The subjects will receive an oral coating of CHG0521 in the form of drops, in addition to the clinician's standard treatment regimen, for a duration of 6 months or until confirmed progression, unacceptable toxicity, or any criteria for withdrawal from the trial.
Sponsors
Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 24 weeks | ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QOL | 24 weeks | Washington Quality of Life Score |
| PCR | 24 weeks | Pathologic Complete Response |
| DRR | 24 weeks | Disease Recurrence Rate |
| OS | 1 year | Overall Survival |
| AEs | 1 year | Incidence and severity of adverse events |
Contacts
Primary ContactGuo Jianwen
Outcome results
None listed