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

NCT ID: NCT06609070

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2026-08-31

Brief Summary

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

Conditions

Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Oral Cavity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug: CHG0521 Oral Coating

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.

Group Type: EXPERIMENTAL

CHG0521 Oral Coating

Intervention Type: DRUG

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.

Interventions

CHG0521 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

jianwen guo, MD

Chief TCM physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Guo Jianwen

Role: CONTACT

jianwen_guo@qq.com

13724899379

Other Identifiers

ZF2024-260-01

Identifier Type: -

Identifier Source: org_study_id