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

Not Applicable

Not yet recruiting

• Conditions: Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Oral Cavity
• Interventions: Drug: CHG0521 Oral Coating

• Registration Number: NCT06609070
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Study Start: 2024-10-15
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug: CHG0521 Oral Coating	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
OS	1 year	Overall Survival
AEs	1 year	Incidence and severity of adverse events
QOL	24 weeks	Washington Quality of Life Score
PCR	24 weeks	Pathologic Complete Response
DRR	24 weeks	Disease Recurrence Rate