Combination Therapy + TACE for Liver Cancer

Recruiting in Palo Alto (17 mi)

Overseen byTim F Greten, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

Background: Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Most people with advanced HCC survive an average of 6 to 9 months. Researchers are evaluating a combination of treatment drugs to delay the progression of HCC; aiming to help people with HCC live longer. Objective: To study the 6-month progression-free survival in people with advanced HCC treated with bevacizumab, durvalumab, and TACE. Eligibility: Adults ages 18 and older with intermediate or advanced HCC Design: Participants will be screened with a physical exam and medical history. They will have tests to evaluate their hearts as well as blood and urine. A CT and/or MRI scans will be done during the study. If a prior tumor sample is not available; participants may undergo a biopsy. They may undergo an endoscopy of their esophagus and stomach. Participants will get the study drugs in 21-day cycles: Two treatment drugs will be injected into a vein every 3 weeks. Patients will have an interventional treatment procedure done by interventional radiology under sedation; chemotherapy beads will be infused into artery branches in the liver. Participants may have to stay in the hospital for 24 hours for observation, after this procedure. This interventional procedure may be done more than once during the study. Participants may need to repeat some of the screening tests throughout the study. Participants may have to stop taking some of their cancer treatment drugs during the study. Participants will continue on the study until their cancer progresses or until the side effects of the treatment drugs are not tolerable.

Research Team

Tim F Greten, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

Adults over 18 with advanced liver cancer (Hepatocellular Carcinoma or Biliary Tract Carcinoma) who've tried standard treatments without success, or can't tolerate them. They should be in good physical condition (ECOG 0-1), have acceptable organ function and blood counts, and no serious heart issues. Women of childbearing age and men must use contraception during the trial.

Inclusion Criteria

My liver cancer is classified as either BCLC stage C or B.

My condition cannot be cured with surgery, ablation, or a liver transplant.

I have recovered from side effects of my previous cancer treatment.

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Exclusion Criteria

My blood pressure is not well-controlled, even with medication.

I do not have HIV.

I am on long-term steroids or other drugs that weaken my immune system.

See 24 more

Treatment Details

Interventions

Bevacizumab (Monoclonal Antibodies)
Doxorubicin-Eluting Beads (Chemotherapy)
Durvalumab (Monoclonal Antibodies)
TACE (Procedure)
Tremelimumab (Monoclonal Antibodies)

Trial OverviewThe trial tests a combination therapy for liver cancer: Durvalumab, Bevacizumab, Tremelimumab injections every three weeks plus TACE - a procedure where chemotherapy beads are delivered directly to the liver tumor. The goal is to see if this combo helps patients live longer without their cancer getting worse.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: 3/Arm 3Experimental Treatment3 Interventions

Durvalumab, low-dose bevacizumab, and tremelimumab

Group II: 2/Arm 2Experimental Treatment5 Interventions

Durvalumab, bevacizumab, tremelimumab and TACE

Group III: 1/Arm 1Experimental Treatment3 Interventions

Durvalumab, bevacizumab and tremelimumab

Bevacizumab is already approved in Japan, Canada for the following indications: