A Single-arm, Multicenter Phase Ib Clinical Trial of the Efficacy and Safety of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Neoadjuvant in the Treatment of Resectable Hepatocellular Carcinoma With a High Risk of Recurrence or Metastasis
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pathological complete response rate (pCR)
研究概览
简要总结
In this study, single cell transcriptome sequencing will be performed on the tissue samples punctured and the surgically resected specimens to explore the gene mutation sites related to efficacy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation and written informed consent;
- •Age: 18-75 years old;ECOG PS：0-1；The expected survival is more than 6 months;
- •No gender limitation;
- •Histologically confirmed hepatocellular carcinoma;
- •Meet resectable surgical criteria;
- •Child-Pugh:A or B;
- •According to RECIST 1.1, there is at least one evaluable lesion that has not been treated;
排除标准
- •Fibrolamellar HCC, sarcomatoid HCC, or mixed bile duct cell-HCC is known to exis;
- •Preoperative systemic treatment including chemotherapy, targeted therapy and immunotherapy;Preoperative local treatment including radiotherapy, interventional therapy and ablative therapy;
- •No radical resection could be performed after adequate imaging evaluation;
- •Present or present with other malignant tumors within 3 years.Two conditions were eligible for inclusion: 5 consecutive years of disease-free survival (DFS) for other malignancies treated with a single operation;Cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)]; 5 . There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- •Hepatitis B combined with hepatitis C;
- •Patients with portal hypertension have high bleeding risk considered by the researcher, or gastroscopy or gastroscopy confirmed red signs, or gastroscopy found active ulcers with high bleeding risk;
研究组 & 干预措施
Anlotinib hydrochloride capsules combined with TQB2450 injection
Anlotinib hydrochloride capsules (10mg po qd, Two weeks off for one week) combined with TQB2450 injection (1200mg ivgtt, q3W)
干预措施: Anlotinib hydrochloride capsules＋ TQB2450 injection (Drug)
结局指标
主要结局
Pathological complete response rate (pCR)
时间窗: 6 months
No histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors.
Overall response rate (ORR)
时间窗: through study completion, an average of 6 months
Objective response rate refers to the percentage of complete (CR) or partial response (PR) subjects determined by the investigator based on RECIST 1.1 .
次要结局
- The incidence and severity of AE(through study completion, an average of 1 year)
- Progression free survival(PFS)(through study completion, an average of 1 year)
- Overall survival (OS)(through study completion, an average of 1 year)
- The incidence and severity of SAE(through study completion, an average of 1 year)
研究者
Hong Zhao
Professor
Chinese Academy of Medical Sciences