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

Guangzhou University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Squamous Cell Carcinoma of the Oral Cavity; Squamous Cell Carcinoma

Treatments: Drug: CHG0521 Oral Coating

Study type: Interventional

Funder types: Other

Identifiers

NCT06609070

ZF2024-260-01

Details and patient eligibility

About

This is a prospective single-arm loading test study of CHG0521 oral coating in patients with solid tissue tumor/recurrent/metastatic TSCC

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

  2. 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.

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

  4. 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.

  5. 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Drug: CHG0521 Oral Coating

Experimental group

Description:

LSCC subjects who are not suitable for surgery after evaluation, or have surgical indications, do not agree to surgical treatment, or patients with recurrence and metastasis after surgery no longer have surgery.

Treatment:

Drug: CHG0521 Oral Coating