YIV-906+Sorafenib for Advanced Hepatocellular Carcinoma (HCC)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Sun Yat-Sen University Cancer Center, Guangzhou, China
Advanced Hepatocellular Carcinoma (HCC)+2 More
YIV-906+Sorafenib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

YIV-906 (Formerly PHY906/KD018) With Sorafenib in HBV(+) Hepatocellular Carcinoma (HCC)

See full description

Eligible Conditions

  • Advanced Hepatocellular Carcinoma (HCC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Advanced Hepatocellular Carcinoma (HCC)

Study Objectives

This trial is evaluating whether YIV-906+Sorafenib will improve 1 primary outcome and 12 secondary outcomes in patients with Advanced Hepatocellular Carcinoma (HCC). Measurement will happen over the course of Continuously throughout the study until 28 days after treatment discontinuation.

Month 24
Disease control rate (DCR) in each arm
Objective response rate (ORR) in each arm
Progression free survival (PFS)
Time to progression (TTP)
Month 24
Change of quality of life (QoL) in each arm with EORTC-C30
Change of quality of life (QoL) in each arm with HCC18
Day 28
The safety and tolerability of the combination of YIV-906 plus sorafenib as measured by the rate and severity of AEs
Week 4
Effects of YIV-906 on mean Cmax (mg/mL) of sorafenib in blood
Week 4
Effects of YIV-906 on mean AUC from time 0 to the end of the dosing period AUC0-tau (mg*h/L) of sorafenib in blood
Effects of YIV-906 on mean AUC0-24(mg*h/L) of sorafenib in blood
Effects of YIV-906 on mean Tmax (Hr) of sorafenib in blood
Effects of YIV-906 on mean t½ (Hr) of sorafenib in blood
Month 24
Overall survival (OS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Advanced Hepatocellular Carcinoma (HCC)

Trial Design

2 Treatment Groups

Sorafenib + Placebo
1 of 2
Sorafenib + YIV-906
1 of 2
Active Control
Experimental Treatment

This trial requires 125 total participants across 2 different treatment groups

This trial involves 2 different treatments. YIV-906+Sorafenib is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Sorafenib + YIV-906
Drug
Patients in the study arm will be treated orally for 28-day courses with YIV-906 + sorafenib
Sorafenib + Placebo
Drug
Patients in the placebo arm will be given sorafenib with placebo

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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 has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 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.

Closest Location

Calvin Pan. MD Gastroenterology & Hepatology Clinic - Flushing, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
"Measurable disease" according to RECIST1.1, i.e. at least one measurable lesion.
Male or females ≥18 years old with ability to take oral drugs
Presence of chronic hepatitis B (HBsAg (+))
Diagnosis of advanced (locally advanced or metastatic) unresectable/inoperable HCC according to the American Association for the Study of Liver Diseases (AASLD) Guidelines (Heimbach et al. 2018) or diagnosis by tissue pathology
Participants categorized to stage B or C based on Barcelona Clinic Liver Cancer (BCLC) staging system
Life expectancy of at least 3 months
Advanced unresectable HCC that have liver limited disease who have failed and are not candidates to local therapies; or patients with extrahepatic disease.
Cirrhotic status of current Child-Pugh class A. Child-Pugh status should be calculated based on clinical findings and laboratory results during the screening period
Never received systemic antitumor therapy
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Patient Q&A Section

Have there been other clinical trials involving yiv-906+sorafenib?

"Results from a recent paper confirmed the strong antitumor activities of sorafenib and suggest that it may be used as monotherapy in hepatocellular carcinoma (HCC)." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, hepatocellular?

"Histologically, HCC is the most common form of [liver cancer](https://www.withpower.com/clinical-trials/liver-cancer) (95%). Tumor staging: staging of the liver, a surgical procedure in which part or all of the liver is removed to treat the cancer. The word carcinoma means “having tumorous parts/growth”.\n" - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma, hepatocellular a year in the United States?

"Around 20,400 new cases of carcinoma, hepatocellular are diagnosed a year in the USA. This accounts for around 18% of new cancer cases a year. The main sites of cancer are the liver and the stomach. The incidence of this cancer is significantly more in men and in persons with a family history of carcinoma. The risk of getting cancer is also proportional to the age: the risk of getting breast cancer is three times the one of getting carcinoma, hepatocellular in adolescence, young adulthood and the middle age. The mortality of cancer, hepatocellular increases significantly with age." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, hepatocellular be cured?

"There has been very little success in curing carcinoma, hepatocellular. This is due to the fact that the cancer often has not reached a stage at which surgery is curative." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, hepatocellular?

"Liver cancer has four distinct forms that are differentiated by their location. Common forms of treatment are for curative purposes only and include surgery, chemotherapy, radiation therapy, and targeted therapy. For some tumors, such as HCC, adjuvant treatment has been shown to improve patient outcome." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, hepatocellular?

"The signs of carcinoma, hepatocellular, vary among races and may depend on the size of the liver and the amount of fat in the liver." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, hepatocellular?

"A wide variety of environmental agents may increase the risk of developing carcinoma, particularly cigarette and hepatitis B virus (HBV) infections. The exact mechanism by which environmental agents transform normal cells into carcinoma remains unclear.\n\nAlthough the genetic component of cancer is well understood, researchers are still unsure of the environmental factors in the development of cancer, including ionizing radiation, lifestyle, diet, and various chemical substances and substances in tobacco smoke. Tobacco smoking, the most significant cause of cancer and cancer death, is linked to a wide variety of diseases and other cancers, such as mouth cancer.\n\nA large number of human cancers are associated with the uncontrolled multiplication of cells." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma, hepatocellular?

"Patients with carcinoma, hepatocellular, living in Hong Kong have a better survival rate than those of other countries. However, this is still lower than that of non-cancerous, and it doesn't affect the quality of life of patients. Patients with carcinoma, hepatocellular, who live in Hong Kong seem to have more chances to be diagnosed earlier, though they didn't die in a hospital earlier than non-cancerous patients. The life expectancy of patients with carcinoma, hepatocellular, was statistically shorter than those of patients with non-cancerous disease." - Anonymous Online Contributor

Unverified Answer

Does carcinoma, hepatocellular run in families?

"Recent findings suggests that HCC run in families; although, the exact genetic basis for these tumors has not been determined, asymptomatic carriers should be followed to confirm their carrier status." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for carcinoma, hepatocellular?

"Recent findings indicate that a minority of patients with cancer are eligible for clinical trials regarding tumor therapy. However, a higher proportion of patients with cancer would be considered eligible for trials focused on the treatment of cancer cachexia." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma, hepatocellular spread?

"We have developed a novel formula to predict the possibility of HCC, based on the combination of the presence of HBsAg, AFP and liver cirrhosis. This is helpful in guiding treatment of HCC." - Anonymous Online Contributor

Unverified Answer

How serious can carcinoma, hepatocellular be?

"Carcinoma, hepatocellular is the most common carcinoma of the liver, accounting for over 90 percent of reported hepatocellular cancers. Since the incidence of hepatocellular carcinoma is most likely to occur in middle-aged Caucasians or Caucasians of African descent, screening programs for hepatocellular cancer should be instituted as early as is feasible in these groups." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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