- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04597970
TACE Plus HAIC With Oxaliplatin and Raltitrexed for BCLC Stage C HCC (OXRI)
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)
Study Overview
Status
Intervention / Treatment
Detailed Description
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:
- Volunteer to participate and sign the informed consent in writing;
- Age: 18-75 years old;
- No gender limit;
- BCLC stage C hepatocellular carcinoma with 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;
- ECOG Performance Status (ECOG) 0-2;
- 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:
- 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 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Xu Zhu
- Phone Number: 86-01088196059
- Email: drzhuxu@163.com
Study Contact Backup
- Name: Baojiang Liu
- Phone Number: 86-01088196059
- Email: lbjjrk@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cTACE-HAIC(oxaliplatin and raltitrexed)
Patients receive cTACE+HAIC (oxaliplatin, raltitrexed) treatment, 6-8 weeks as a cycle
|
transarterial chemoembolization (TACE) plus Hepatic Arterial Infusion Chemotherapy (HAIC) with oxaliplatin and raltitrexed for Barcelona stage C hepatocellular carcinoma (HCC)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate, ORR
Time Frame: 6 months
|
The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate
|
6 months
|
Disease control rate, DCR
Time Frame: 6 months
|
disease control rate (DCR) was defined as the CR rate + the PR rate + the stable disease (SD) rate
|
6 months
|
Progression free overall survival,PFS
Time Frame: 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
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival, OS
Time Frame: 25 months
|
overall survival (OS) was defined as the interval between the time at which treatment was initiated and death or the last follow-up assessment
|
25 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Xu Zhu, Peking University Cancer Hospital & Institute
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020YJZ41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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