CHG0521 Oral Coating; TSCC
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a prospective single-arm loading test study of CHG0521 oral coating in patients with solid tissue tumor/recurrent/metastatic TSCC
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18-80 years, encompassing both males and females.
- •Confirmation of tongue squamous cell carcinoma through histopathology or cytology is required.
- •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.
- •No concurrent use of other traditional Chinese medicine orally or externally within the past 3 months.
- •Presence of at least one measurable lesion according to RECIST 1.1 criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Expected survival time should be equal to or greater than 3 months.
- •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.
排除标准
- •Patients with tongue squamous cell carcinoma who have undergone tumor resection without any residual tumor;
- •Patients with a known allergy to any therapeutic ingredient or a history of hypersensitivity or allergic constitution;
- •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;
- •Patients with a history of immune deficiency, organ transplantation, or allogeneic bone marrow transplantation;
- •Patients currently enrolled in another concurrent clinical study;
- •Pregnant and lactating women.
研究组 & 干预措施
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.
干预措施: CHG0521 Oral Coating (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 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.
次要结局
- OS(1 year)
- AEs(1 year)
- QOL(24 weeks)
- PCR(24 weeks)
- DRR(24 weeks)
研究者
jianwen guo, MD
Chief TCM physician
Guangzhou University of Traditional Chinese Medicine