Study on Regorafenib and Durvalumab for Treating High-Risk Liver Cancer

Sponsor: Academic and Community Cancer Research United

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05194293

Provider View

This clinical trial is exploring whether a combination of the drugs regorafenib and durvalumab can effectively shrink tumors in patients with high-risk liver cancer. Regorafenib may block enzymes that help cancer cells grow, while durvalumab, an immunotherapy, may help the immune system attack cancer cells.

Patient Parameters

Program Overview

The purpose of this phase II study is to test if the combination of regorafenib and durvalumab can reduce tumor size in patients with high-risk liver cancer. Regorafenib works by blocking certain enzymes that cancer cells need to grow. Durvalumab is an immunotherapy that may help the immune system target and destroy cancer cells. The study aims to see if using both drugs together is more effective in treating high-risk liver cancer.

Description

Primary Objective:

  • To evaluate the overall response rate (ORR) at 16 weeks after starting the study.

Secondary Objectives:

  • To see how many patients can have surgery during the study.
  • To assess the safety and side effects of the combination of regorafenib and durvalumab.
  • To evaluate the impact of the treatment on overall survival.
  • To assess how long patients live without the cancer getting worse if they don't have surgery.
  • To evaluate how long patients live without the cancer returning if they do have surgery.
  • To see how many patients achieve a complete response to the treatment.

Research Objective:

  • To study how regorafenib and durvalumab affect immune markers in the tumor and blood.

Treatment Plan:

Patients will take regorafenib by mouth once a day for 21 days and receive durvalumab through an IV on the first day. This treatment cycle repeats every 28 days for up to 2 years or until surgery, disease progression, severe side effects, or patient withdrawal. After treatment, patients will have follow-up visits every 90 days for 3 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Weigh more than 30 kg (about 66 pounds).
  • Have a confirmed diagnosis of hepatocellular carcinoma (HCC) by specific medical criteria.
  • Have measurable cancer.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have a Child Pugh class A liver function.
  • Have specific blood test results within normal limits.
  • Be able to swallow oral medication.
  • Have a life expectancy of at least 12 weeks.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.
  • Agree to return for follow-up visits and provide tissue or blood samples for research.
  • Have specific cancer staging according to medical guidelines.
  • Provide informed consent to participate in the study.

Exclusion Criteria

  • Have had previous treatment with similar drugs or therapies for liver cancer.
  • Have a mixed type of liver cancer or fibrolamellar HCC.
  • Have had a significant upper gastrointestinal bleed within 6 months.
  • Have had liver-directed therapy within 28 days before starting the study.
  • Have cancer that has spread outside the liver.
  • Be suitable for a liver transplant.
  • Be participating in another clinical study with investigational drugs within 90 days before starting this study.
  • Have unresolved side effects from previous cancer treatments, except for certain conditions.
  • Be receiving other cancer treatments or investigational drugs.
  • Have had major surgery within 28 days before starting the study.
  • Have a history of organ transplantation.
  • Have active or past autoimmune or inflammatory disorders, with some exceptions.
  • Have uncontrolled illnesses or infections.
  • Have a history of another primary cancer, with some exceptions.
  • Have a specific heart condition as shown by an ECG.
  • Be immunocompromised or have active infections like tuberculosis or hepatitis.
  • Have used immunosuppressive medication within 14 days before starting the study, with some exceptions.
  • Have received a live vaccine within 30 days before starting the study.
  • Be pregnant or breastfeeding, or not willing to use effective birth control during and after the study.
  • Have known allergies to the study drugs or their components.
  • Have participated in a previous durvalumab study.

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