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Trial Title:
CHG0521 Oral Coating in Patients with Solid Tissue Tumor/Recurrent/Metastatic TSCC
NCT ID:
NCT06609070
Condition:
Squamous Cell Carcinoma
Squamous Cell Carcinoma of the Oral Cavity
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CHG0521 Oral Coating
Description:
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.
Arm group label:
Drug: CHG0521 Oral Coating
Summary:
This is a prospective single-arm loading test study of CHG0521 oral coating in patients
with solid tissue tumor/recurrent/metastatic TSCC
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
October 15, 2024
Completion date:
August 31, 2026
Lead sponsor:
Agency:
Guangzhou University of Traditional Chinese Medicine
Agency class:
Other
Source:
Guangzhou University of Traditional Chinese Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06609070
