TACE Combined With Anlotinib Treatment of Middle-advanced Hepatocellular Carcinoma (HCC) Patients
A Single-center Randomized Controlled Clinical Trial of TACE Combined With Anlotinib Comparing With TACE in the Treatment of Middle-advanced Hepatocellular Carcinoma (HCC) Patients
1 other identifier
interventional
40
1 country
1
Brief Summary
This study was designed to evaluate the effectiveness of Anlotinib in middle-advanced Hepatocellular Carcinoma (HCC) Patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2019
1 active site
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
August 22, 2019
CompletedFirst Posted
Study publicly available on registry
August 26, 2019
CompletedStudy Start
First participant enrolled
August 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2021
CompletedAugust 26, 2019
August 1, 2019
1.8 years
August 22, 2019
August 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
PFS
Progress Free Survival
12 months
Study Arms (2)
TACE group
ACTIVE COMPARATORDevice: Transcatheter arterial chemoembolization(TACE)
TACE+Anlotinib group
EXPERIMENTALDevice: Transcatheter arterial chemoembolization Drug: Anlotinib Anlotinib hydrochloride capsule, according to the recommended dose, po, qd, continuous oral 2 weeks stop for 1 week, 3 weeks for a cycle.
Interventions
The modified Seldinger puncture was used to puncture the cutaneous-femoral artery, insert the catheter and perform hepatic artery angiography. The location, morphology and blood supply of liver tissue lesions were comprehensively understood. The use of chemotherapeutic drugs and the dosage of iodized oil as the embolic agent were determined according to the general situation. The catheter was injected into the supply vessel of the tumor, and 5-FU and adriamycin were injected according to the situation. The embolic agent was injected with iodized oil as carrier, mixed with chemotherapeutic drugs at the same time, and then assisted with gelatin sponge for embolization. Antiemetic drugs were given before treatment and hepatoprotective drugs were given after operation. Until the disease progresses.
Anlotinib hydrochloride capsule, according to the recommended dose, po, qd, continuous oral 2 weeks stop for 1 week, 3 weeks for a cycle.
Eligibility Criteria
You may qualify if:
- Subject has no contraindication to chemotherapy, and has no obvious obstacles in the function of major organs such as heart, lung, liver and kidney;
- Subject has middle-advanced liver cancer of Barcelona Clinic Liver Cancer stages B/C ;
- Liver function child-pugh class A or B; Karnofsky (KPS) score \> 60 points;
- Subject could not accept surgical resection or refuse surgical operation;and who did not receive other treatment before operation.
- \~75 years old; ECOG PS score: 0-1 points; expected survival period is more than 3 months.
You may not qualify if:
- Subject has contraindications to chemotherapy;
- Subject has obstacle in the function of major organs such as heart, lung, liver and kidney;
- Severe coagulation dysfunction (prothrombin time \> 18 s or hemorrhagic tendency);
- Uncontrollable hypertension and portal hypertension;
- Hepatic artery-portal vein or hepatic vein fistula or portal vein trunk cancer thrombus;
- A large amount of ascites or refractory ascites;
- With distant metastasis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Related Publications (1)
Zhang D, Zhang Z, Luo J, Zheng J, Mao X, Tsilimigras DI, Chun HJ, Zeng H. Efficacy and safety of transarterial chemoembolization alone compared to its combination with anlotinib among patients with intermediate or advanced stage hepatocellular carcinoma: a phase II randomized controlled trial. J Gastrointest Oncol. 2024 Aug 31;15(4):1627-1635. doi: 10.21037/jgo-24-497. Epub 2024 Aug 28.
PMID: 39279973DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guoliang Shao
Zhejiang Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2019
First Posted
August 26, 2019
Study Start
August 30, 2019
Primary Completion
May 30, 2021
Study Completion
October 30, 2021
Last Updated
August 26, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share