HAIC Combine With Lenvatinib and Camrelizumab for Advanced HCC With PVTT
-
- STATUS
- Recruiting
-
- End date
- Dec 22, 2024
-
- participants needed
- 66
-
- sponsor
- Peking University
Summary
The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy combined with Lenvatinib and Camrelizumab compared to Lenvatinib plus Camrelizumab for advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT).
Description
Hepatic arterial infusion chemotherapy (HAIC) can significantly improve the local drug concentration in liver compared to systemic chemotherapy. The efficacy of HAIC for hepatocellular (HCC), cholangiocarcinoma, gallbladder, and colorectal carcinoma liver metastasis has been proved by many published studies. HAIC with oxaliplatin and 5-fluorouracil could significantly prolong survival time for HCC patients with portal vein tumor thrombosis (PVTT). Lenvatinib, as a new oral anti-neovascularity inhibitor, was proved to have similar efficacy in HCC patients compared to sorafenib in REFLECT study. The sub-group analysis showed that the median overall survival (OS) in Lenvatinib group was significantly longer that sorafenib group in Chinese HCC patients. As a programmed death-1 inhibitor, Camrelizumab showed its efficacy in advanced HCC patients as second-line therapy, with the 6-month survival rate of 74.7%, median progression-free survival (PFS) of 2.1 months, and median OS of 14.4 months. Thus, the investigators carried out this prospective controlled trial to compare the efficacy and safety of HAIC combined with Lenvatinib and Camrelizumab and Lenvatinib and Camrelizumab for advanced HCC with PVTT.
Total 66 subjects will be recruited in this trial, each group of 33 subjects in treatment group (HAIC-Cola group) and control group (Cola group). The primary endpoint is six-month progression-free survival rate, and the secondary endpoints are OS, overall response rate (ORR), PFS, time-to-progression (TTP) and safety. The safety evaluation will be carried out according to the standard of adverse reaction classification (Common Terminology Criteria for Adverse Events, CTCAE v5.0).
Details
| Condition | Hepatocellular Carcinoma, Portal Vein Thrombosis |
|---|---|
| Treatment | HAIC, Lenvatinib 1, Camrelizumab 1, Lenvatinib 2, Camrelizumab 2 |
| Clinical Study Identifier | NCT05166239 |
| Sponsor | Peking University |
| Last Modified on | 22 March 2022 |
Eligibility
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer