Durvalumab for Carcinoma, Hepatocellular

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Research Site, München, Germany
Carcinoma, Hepatocellular+3 More
Durvalumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of two drugs may help treat liver cancer.

See full description

Eligible Conditions

  • Carcinoma, Hepatocellular
  • Hepatocellular Carcinoma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Carcinoma, Hepatocellular

Study Objectives

This trial is evaluating whether Durvalumab will improve 1 primary outcome and 5 secondary outcomes in patients with Carcinoma, Hepatocellular. Measurement will happen over the course of No timeframe.

Month 36
Recurrence-free survival at 24 months (RFS24) and 36 months (RFS36) for Arm A vs Arm C and Arm B vs Arm C
No timeframe
Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C
Month 49
Recurrence-free survival (RFS) Arm B vs Arm C
Recurrence-free survival (RFS) for Arm A vs Arm C
Time from randomization to recurrence/progression on next therapy (RFS2/PFS2) for Arm A vs Arm C and Arm B vs Arm C
Time to recurrence (TTR) for Arm A vs Arm C and Arm B vs Arm C

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Carcinoma, Hepatocellular

Trial Design

3 Treatment Groups

Arm A
1 of 3
Arm B
1 of 3
Arm C
1 of 3
Experimental Treatment
Non-Treatment Group

This trial requires 877 total participants across 3 different treatment groups

This trial involves 3 different treatments. Durvalumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Arm ADurvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W)
Arm BDurvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W)
Arm C
Other
Durvalumab placebo (Q3W) + bevacizumab placebo (Q3W)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 24 and at 36 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at 24 and at 36 months for reporting.

Closest Location

Research Site - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Carcinoma, Hepatocellular or one of the other 3 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
Imaging to confirm disease-free status within 28 days prior to randomization
ECOG 0-1 at enrolment
Child-Pugh score of 5 or 6
Adequate organ and marrow function.

Patient Q&A Section

What are common treatments for carcinoma, hepatocellular?

"The most common treatments for carcinoma, hepatocellular include surgery, radiation, chemotherapy, and targeted therapy. Other options may include hepatic artery embolization, immunotherapy, and liver transplantation." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, hepatocellular?

"In our case study the following signs was detected: pain, jaundice, hematemesis, constipation, dyspepsia and increased erythrocyte sedimentation rate. Among the signs, the most obvious are gastrointestinal and hepatic.\n" - Anonymous Online Contributor

Unverified Answer

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

"The total number of cases of carcinoma hepatocellular in the United States is increasing yearly, and the 5-year rate continues to rise. Overall, men were at an increased risk compared with women, and for all ages, Hispanics were at increased risk." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, hepatocellular?

"The cause of hepatocellular carcinoma is not clear, but is intimately related to viral infection, environmental chemicals and hereditary factors. Many risk factors combine to cause carcinomas of the liver. The diagnosis of carcinoma, hepatocellular requires biopsy for pathology and immunohistochemical analyses for specific viral markers." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, hepatocellular be cured?

"Hepatic carcinoma, hepatocellular is a hard tumor that usually can not be cured. However, the long-term survival can be promoted when a cure for a hepatocellular carcinoma is obtained. The curative treatment of hepatocellular carcinoma must be developed." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, hepatocellular?

"Carcinoma, hepatocellular, is a disease of the liver in which malignant tumor cells invade the liver. This tumor is relatively common in both non-Hispanic males and females over 30 years of age in the US and can have a devastating effect on the patient and his/her family." - Anonymous Online Contributor

Unverified Answer

What is the latest research for carcinoma, hepatocellular?

"The study concludes that new anti-cancer drugs will be developed in the near future for hepatocellular carcinoma. It shows that gene therapy (silent gene therapy) and gene editing technologies may be used in hepatocellular carcinoma therapy in the future." - Anonymous Online Contributor

Unverified Answer

Does durvalumab improve quality of life for those with carcinoma, hepatocellular?

"Durvalumab significantly improves P-QOL, TFI and QWL in patients with advanced HCCs. It also improves WPRQOL and QWBQOL. Durvalumab has the potential to be an effective treatment for those with advanced HCC." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in durvalumab for therapeutic use?

"The safety and efficacy of durvalumab were demonstrated in two pivotal phase III trials. Durvalumab may benefit patients with advanced or metastatic HCC. The safety and efficacy of durvalumab were additionally demonstrated in two additional, smaller cohorts. Future clinical trials will confirm the safety and efficacy of further indications of durvalumab. In addition to its use in mHCC, we believe that durvalumab represents an important advance against advanced form of HCC." - Anonymous Online Contributor

Unverified Answer

What is durvalumab?

"Durvalumab is a medication that is effective as an immunomodulatory agent in metastatic NSCLC. It is a monoclonal antibody targeted against PD-1 that is given by an intravenous injection. It is already being used in several cancers and is an exciting new treatment in cancer patients with metastatic NSCLC, particularly those with mismatch repair gene, bRAF, or ALK alterations." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma, hepatocellular spread?

"These data indicate that CCL18 and its receptor CCR3 expression might be the key mechanisms of cancer cell invasion of metastatic site, and that CCL18/CCR3 signaling may be an important target by which chemotherapy can control CCL18 and metastasis." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets carcinoma, hepatocellular?

"It is rare on average for anyone to experience a first diagnosis of HCC at age 45 or under. A second HCC diagnosis can occur from age 35 to about 50 years with a peak rate around age 45 but the majority of patients experienced their first HCC diagnoses after age 40." - 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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