Last updated: September 23, 2022
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting
Phase
2
Condition
Liver Cancer
Carcinoma
Treatment
N/AClinical Study ID
NCT05555316
TALEM
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients aged 18-75 years with hepatocellular carcinoma have an expected survival ofat least 3 months;
- Number of tumors ≤ 3;
- Large hepatocellular carcinoma with tumor diameter ≥ 7 cm;
- Patients without inferior vena cava tumor thrombus, portal vein tumor thrombus andcholangiocarcinoma thrombus;
- Although there is arteriovenous fistula or arterioportal fistula, it can be completelyblocked;
- Child Pugh grade A or B of liver function; ECoG physical fitness score < 2;
- No bleeding tendency, normal coagulation function or coagulation dysfunction can becorrected after treatment;
- Leukocyte count ≥ 3.0 × 109/L;
- Hemoglobin ≥ 8.5g/dl;
- Platelet count ≥ 50 × 109/L;
- The international normalized ratio of prothrombin time (INR) ≤ 2.3 or prothrombin time (PT) does not exceed the upper limit of normal control for 3 seconds;
- Serum creatinine was less than 1.5 times of the upper limit of normal;
- Patients and / or family members agree to join the clinical trial and sign theinformed consent form
Exclusion
Exclusion Criteria:
- Diffuse hepatocellular carcinoma;
- Portal vein tumor thrombus;
- Combined with tumor thrombus of hepatic vein and inferior vena cava;
- Patients with lymph node metastasis and extrahepatic distant metastasis;
- The liver function was classified as child Pugh C and could not be improved by liverprotection treatment;
- Arteriovenous fistula or arterioportal fistula with ineffective intervention;
- Uncorrectable coagulation dysfunction and obvious hemogram abnormalities, with obviousbleeding tendency;
- Intractable massive ascites;
- ECoG physical fitness score > 2 points;
- Combined with active infection, especially bile duct inflammation;
- Serious heart, lung, kidney, brain and other important organ diseases;
- Note: see attached table 1 for child Pugh classification of liver function; Seeattached table 2 for ECoG physical fitness score
Study Design
Total Participants: 46
Study Start date:
November 10, 2019
Estimated Completion Date:
November 30, 2023
Study Description
Connect with a study center
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaActive - Recruiting
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