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Kinase Inhibitor

YIV-906 + Sorafenib for Hepatocellular Carcinoma

Phase 2

Recruiting

Research Sponsored by Yiviva Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Serum alanine amino-transferase (ALT) ≤ 5 x ULN

Adequate renal function, based upon meeting the following laboratory criteria within 7 days before randomization:

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upat randomization, then at the end of every two cycle (i.e. approximately every 8 weeks), until death from any cause. assessed up to 24 months.

Awards & highlights

Study Summary

This trial is testing if YIV-906, an extract of four herbs, can help fight Hepatitis B associated advanced liver cancer when used with the standard-of-care treatment, sorafenib.

Eligible Conditions

Liver Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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Participants categorized to stage B or C based on Barcelona Clinic Liver Cancer (BCLC) staging system.

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You are expected to live for at least three more months.

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You have liver cancer that cannot be removed by surgery and all other treatment options have been exhausted or are not suitable for you. Additionally, you may have cancer that has spread outside of the liver.

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You are expected to live for at least 3 more months.

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You have advanced liver cancer that cannot be surgically removed and have already tried other treatments without success. Alternatively, you have liver cancer that has spread to other parts of your body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at randomization, then at the end of every two cycle (i.e. approximately every 8 weeks), until death from any cause. assessed up to 24 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at randomization, then at the end of every two cycle (i.e. approximately every 8 weeks), until death from any cause. assessed up to 24 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at randomization, then at the end of every two cycle (i.e. approximately every 8 weeks), until death from any cause. assessed up to 24 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression free survival (PFS)

Secondary outcome measures

Change of quality of life (QoL) in each arm with EORTC-C30

Change of quality of life (QoL) in each arm with HCC18

Disease control rate (DCR) in each arm

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sorafenib + YIV-906Experimental Treatment1 Intervention

Patients in the study arm will be treated orally for 28-day courses with YIV-906 + sorafenib

Group II: Sorafenib + PlaceboActive Control1 Intervention

Patients in the placebo arm will be given sorafenib with placebo

0 / 21Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yiviva Inc.Lead Sponsor

Ghassan Abou-Alfa, MD/MBAStudy ChairMemorial Sloan Kettering Cancer Center

Yun Yen, MD/PhDStudy ChairTaipei Medical University

Media Library

Sorafenib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04000737 — Phase 2

Liver Cancer Research Study Groups: Sorafenib + YIV-906, Sorafenib + Placebo

Liver Cancer Clinical Trial 2023: Sorafenib Highlights & Side Effects. Trial Name: NCT04000737 — Phase 2

Sorafenib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04000737 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other drugs have been studied alongside YIV-906+Sorafenib?

"Currently, there are 65 ongoing clinical trials studying the efficacy of YIV-906+Sorafenib. Out of those, 24 have reached Phase 3 testing. Most of these studies taking place in Taibei, Taiwan; though there are 2804 research sites for this medication globally."

Answered by AI

Are recruitment efforts for this research still ongoing?

"The date on clinicaltrials.gov suggests that this study is still looking for patients to enroll. This trial was first announced on January 10th 2020 with the most recent update being from July 11th 2022."

Answered by AI

What is YIV-906+Sorafenib generally prescribed for?

"YIV-906+Sorafenib is an effective treatment for progressive, metastatic radioactive iodine-refractory differentiated thyroid carcinoma (dtc) as well as other conditions such as gastrointestinal stromal tumors, leiomyosarcoma d thyroid carcinoma (dtc) as well as other conditions such as gastrointestinal stromal tumors, leiomyosarcoma, and hemangiosarcoma."

Answered by AI

Is it dangerous to take YIV-906+Sorafenib?

"There is limited data to support the safety of YIV-906+Sorafenib, as this medication is still in Phase 2 clinical trials."

Answered by AI

With how many individuals is this experiment being conducted?

"That is correct. According to the latest information on clinicaltrials.gov, this trial is still recruiting patients. This particular study was first posted on 1/10/2020, and the website was updated as recently as 7/11/2022. The research team is looking for 125 people total, but they need to be at one of the two locations."

Answered by AI