NCT06184841已完成1 期
Hepatic Arterial Infusion Chemotherapy Combined Sintilimab for Predominant Liver Metastasis From Esophageal Squamous Cell Carcinoma- A Pilot Study
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年6月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
Patients with liver metastasis from esophagus squamous (ESC) are usually offered systemic therapy. However, for those with predominant liver disease or failure of system therapy, local liver management becomes an option. This prospective single center study aimed to evaluate the efficacy and adverse events of hepatic arterial infusion chemotherapy (HAIC) using percutaneous catheter placement techniques for liver metastases from esophagus squamous (ESC).
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
- •Both male and female, aged 18-75 years;
- •ECOG score 0-1;
- •Pathological diagnosis: metastatic esophageal squamous cell carcinoma confirmed by histological or cytological examination (excluding adenosquamous carcinoma mixed type and other pathological types).
- •Metachronous liver metastasis after esophagectomy, especially when liver was the only metastatic organ, or synchronous liver metastasis progressed after first-line medical treatment; Or liver metastasis is currently the main threat, and control of liver metastasis should be the main goal
- •predicted survival time ≥3 months.
- •Liver function: Child-Pugh score 5-
- •ALT, AST, ALP< 2.5 times upper limit of normal, total bilirubin< 1.5 times upper limit of normal, PT, INR were < 1.5 times upper limit of normal, respectively. Bone marrow function was good (white blood cell ≥3.0 x 109/L, granulocyte ≥1.5 x 109/L, platelet ≥75 x 109/L, HGB≥100g/l), renal function was good (BUN < 40mg/dl, creatinine < 2mg/ml).
- •HBV infection, should have effective antiviral treatment, HBV DNA < 100IU/ml.
- •agree to be enrolled in the study, be willing to cooperate with the clinical research, and sign the informed consent.
- •Female subjects of childbearing age or male subjects whose sexual partner is a female of childbearing age should use effective contraception during the entire treatment period and for 6 months after the treatment period.
排除标准
- •age > 75 years old;
- •ECOG score ≥2;
- •poor liver function, Child-Pugh score > 7, or liver enzyme, coagulation, bilirubin and bone marrow function did not meet the inclusion criteria.
- •History of esophagogastric bleeding, hepatic encephalopathy, massive ascites, and abdominal infection.
- •lung, bone, mediastinal lymph nodes, multiple lower abdominal lymph nodes, pelvic lymph nodes and other distant metastases, unable to receive local radiotherapy.
- •The tumor was close to the intestinal tract and other organs, and it was difficult to tolerate interventional therapy; Patients with residual liver volume less than 800ml and difficult to tolerate interventional therapy.
- •allergic to Sintilimab.
- •patients had received previous immunotherapy, such as PD-1 antibody, PD-L1 antibody, CTLA4 antibody.
- •use of immunosuppressive drugs within the previous 4 weeks, excluding intranasal, inhaled, or other topical glucocorticoids or physiological doses of systemic glucocorticoids (i.e., no more than 10 mg/ day of prednisone or the equivalent dose of other glucocorticoids), and temporary use of glucocorticoids for the treatment of dyspnea in conditions such as asthma, chronic obstructive pulmonary disease, etc.
研究组 & 干预措施
esophageal squamous cell carcinoma with liver metastasis
Experimental
Patients with esophageal squamous cell carcinoma with liver metastasis have poor response to first-line treatment, especially those with advanced esophageal cancer with progression or recurrence in the liver.
干预措施: HAIC combined with intravenous PD-1 (Drug)
结局指标
主要结局
Adverse Events
时间窗: Up to 2 years
Defined as the proportion of patients with Adverse events (AEs), Treatment Emergent Adverse events (TEAEs), Treatment-related AEs (TRAEs), immune-related AEs (irAEs), adverse events of special interest (AESI) and Serious Adverse events (SAE), assessed by NCI CTCAE v5.0
次要结局
- The response rate of liver metastases(Up to 2 years)
- The time to response (TTR)(Up to 2 years)
- The overall survival (OS)(Up to 2 years)
- The overall response rate ( ORR)(Up to 2 years)
- The duration of response (DOR)(Up to 2 years)
- The progression free survival (PFS)(Up to 2 years)
研究者
Guang Cao
Principal Investigator
Peking University Cancer Hospital & Institute
研究点 (1)
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