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)
1 other identifier
interventional
66
0 countries
N/A
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2020
CompletedStudy Start
First participant enrolled
October 20, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2022
CompletedOctober 22, 2020
October 1, 2020
1 year
October 16, 2020
October 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Objective response rate, ORR
The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate
6 months
Disease control rate, DCR
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
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 Outcomes (1)
Overall survival， OS
25 months
Study Arms (1)
cTACE-HAIC(oxaliplatin and raltitrexed)
EXPERIMENTALPatients receive cTACE+HAIC (oxaliplatin, raltitrexed) treatment, 6-8 weeks as a cycle
Interventions
transarterial chemoembolization (TACE) plus Hepatic Arterial Infusion Chemotherapy (HAIC) with oxaliplatin and raltitrexed for Barcelona stage C hepatocellular carcinoma (HCC)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xu Zhu
Peking University Cancer Hospital & Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Hospital Chief Physician，MD
Study Record Dates
First Submitted
October 16, 2020
First Posted
October 22, 2020
Study Start
October 20, 2020
Primary Completion
October 20, 2021
Study Completion
October 20, 2022
Last Updated
October 22, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share