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临床试验/NCT04597970
NCT04597970Unknown2 期

A Phase II Clinical Study of Transarterial Chemoembolization (TACE) Plus Hepatic Arterial Infusion Chemotherapy (HAIC) With Oxaliplatin and Raltitrexed for Barcelona Stage C Hepatocellular Carcinoma (HCC)

Peking University Cancer Hospital & Institute0 个研究点目标入组 66 人开始时间: 2020年10月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
66
主要终点
Disease control rate, DCR

研究概览

简要总结

Purpose:explore the effectiveness and safety of transarterial chemoembolization (TACE) plus Hepatic Arterial Infusion Chemotherapy (HAIC) with oxaliplatin and raltitrexed for Barcelona stage C hepatocellular carcinoma (HCC)

详细描述

Thhis is a non-randomized, open, single-arm clinical study. patients receive cTACE+HAIC (oxaliplatin, raltitrexed) treatment, 6-8 weeks as a cycle, until the disease progresses, intolerable toxicity occurs, the patient is lost to follow-up or death, or situations other judged by researchers which treatment should be stopped.

Number of patients: 66 patients End points:primary end points:safety 、objective response rate,disease control rate,progression free overall survival,second end point :overall survival Include criteria:

  1. Volunteer to participate and sign the informed consent in writing;
  2. Age: 18-75 years old;
  3. No gender limit;
  4. BCLC stage C hepatocellular carcinoma with pathological diagnosis or clinical diagnosis;
  5. Barcelona stage C patients who failed first-line treatment (including but not limited to sorafenib, levatinib, atelizumab combined with bevacizumab, etc.); they have not received sorafenib in the past The patients treated by Sorafenib can receive sorafenib treatment at the same time, and the patients who have received sorafenib treatment progress can also receive regorafenib treatment.
  6. At least one measurable lesion (according to mRECIST criteria) imaging diagnosis time ≤ 21 days from selection;
  7. Child-pugh grade A-B7 grade
  8. The expected survival period is ≥3 months;
  9. ECOG Performance Status (ECOG) 0-2;
  10. Sufficient bone marrow hematopoietic function (within 7 days): hemoglobin ≥9 g/dL, white blood cells ≥3.0×109/L, neutrophils ≥1.5x109/L, platelets ≥80x109/L; liver and kidney functions are normal (Within 14 days): TBIL≤1.5 times the upper limit of normal; ALT and AST≤5 times the upper limit of normal; creatinine≤1.5 times the upper limit of normal; INR<1.7 or prolonged PT<4s

Exclude criteria:

  1. Those who are currently receiving other effective treatments;
  2. Patients who have received oxaliplatin and raltitrexed in the past;
  3. Patients who have participated in other clinical trials within 4 weeks before enrollment;
  4. Unable to cooperate with cTACE and HAIC treatment;
  5. Patients with primary malignant tumors other than hepatocellular carcinoma at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
  6. Clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or a history of myocardial infarction within the past 1 year;
  7. Neurological or mental abnormalities that affect cognitive ability, including central nervous system transfer;
  8. There were active serious clinical infections (>grade 2 NCI-CTCAE version 4.0), including active tuberculosis within 14 days before enrollment;
  9. Known or self-reported HIV infection;
  10. Uncontrolled systemic diseases, such as poorly controlled diabetes;
  11. Known to have hypersensitivity or allergic reactions to any component of the study drug;
  12. Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding Treatment:patients receive cTACE+HAIC (oxaliplatin, raltitrexed) treatment, 6-8 weeks as a cycle, until the disease progresses, intolerable toxicity occurs, the patient is lost to follow-up or death, or situations other judged by researchers which treatment should be stopped.

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

入选标准

  • Volunteer to participate and sign the informed consent in writing;
  • Age: 18-75 years old;
  • No gender limit;
  • BCLC stage C hepatocellular carcinoma with clear pathological diagnosis or clinical diagnosis;
  • Barcelona stage C patients who failed first-line treatment (including but not limited to sorafenib, levatinib, atelizumab combined with bevacizumab, etc.); they have not received sorafenib in the past The patients treated by Sorafenib can receive sorafenib treatment at the same time, and the patients who have received sorafenib treatment progress can also receive regorafenib treatment.
  • At least one measurable lesion (according to mRECIST criteria) imaging diagnosis time ≤ 21 days from selection;
  • Child-pugh grade A-B7 grade
  • The expected survival period is ≥3 months;
  • General physical condition (ECOG) 0-2;
  • Sufficient bone marrow hematopoietic function (within 7 days): hemoglobin ≥9 g/dL, white blood cells ≥3.0×109/L, neutrophils ≥1.5x 109/L, platelets ≥80x 109/L; liver and kidney functions are normal (Within 14 days): TBIL≤1.5 times the upper limit of normal; ALT and AST≤5 times the upper limit of normal; creatinine≤1.5 times the upper limit of normal; INR<1.7 or prolonged PT<4s

排除标准

  • Those who are currently receiving other effective treatments;
  • Patients who have received oxaliplatin and raltitrexed in the past;
  • Patients who have participated in other clinical trials within 4 weeks before enrollment;
  • Unable to cooperate with cTACE and HAIC treatment;
  • Patients with primary malignant tumors other than hepatocellular carcinoma at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
  • Clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or a history of myocardial infarction within the past 1 year;
  • Neurological or mental abnormalities that affect cognitive ability, including central nervous system transfer;
  • There were active serious clinical infections (>grade 2 NCI-CTCAE version 4.0), including active tuberculosis within 14 days before enrollment;
  • Known or self-reported HIV infection;
  • Uncontrolled systemic diseases, such as poorly controlled diabetes;
  • Known to have hypersensitivity or allergic reactions to any component of the study drug;
  • Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding

研究组 & 干预措施

cTACE-HAIC(oxaliplatin and raltitrexed)

Experimental

Patients receive cTACE+HAIC (oxaliplatin, raltitrexed) treatment, 6-8 weeks as a cycle

干预措施: cTACE-HAIC (Drug)

结局指标

主要结局

Disease control rate, DCR

时间窗: 6 months

disease control rate (DCR) was defined as the CR rate + the PR rate + the stable disease (SD) rate

Objective response rate, ORR

时间窗: 6 months

The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate

Progression free overall survival,PFS

时间窗: 8 months

PFS was defined as the interval between the time at which treatment was initiated and intrahepatic tumor and/or extrahepatic tumor progression, symptomatic progression, including massive ascites and liver function that was categorized as Child-Pugh grade C, or death from any cause

次要结局

  • Overall survival, OS(25 months)

研究者

发起方
Peking University Cancer Hospital & Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhu Xu

Hospital Chief Physician,MD

Peking University Cancer Hospital & Institute

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