Hepatocellular Carcinoma study: Chemotherapy/Radiation
Official title Radiation Therapy Followed by Durvalumab (MEDI4736) and Tremelimumab And Surgery Versus Radiation Therapy Followed by Surgery for Resectable Hepatocellular Carcinoma.
ClinicalTrials.gov ID: NCT07027436
What this study is testing
What is Chemotherapy/Radiation?
This is an investigational combination of radiation and chemotherapy being studied for Hepatocellular Carcinoma (HCC). It is designed to use radiation and chemotherapy together to change the tumor environment by reducing certain immune cells that help the tumor and increasing immune cells that fight it.
Also referred to as Group 1.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to see if combining radiation with two immune-boosting drugs changes the tumor's environment more than radiation alone. It also checks if these changes lead to better results after surgery.
- Who it's for
- People with liver cancer that can be removed by surgery.
- What's involved
- Participants will receive radiation therapy. Some will also get two immune-boosting drugs (durvalumab and tremelimumab) before having their tumor removed by surgery.
- Time commitment
- The study involves a short period of treatment before surgery to collect tissue samples for testing.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Radiologically or biopsy proven solitary HCC without biliary invasion or metastases, Liver Imaging Reporting and Data Systems (LI- RADS) 4 or 5 only.
- Tumour less than 12 cm in maximum size on CT or MRI.
- Planned surgical resection of HCC with a life expectancy of at least 12 weeks
- Age \>18 years at time of study entry.
- Child-Pugh Class A within 14 days prior to study enrollment
You likely can't join if
- Previous therapy for HCC, including systemic therapy, surgery, radiation therapy, ablation or embolization.
- Participation in another clinical study with an investigational product during the last 4 weeks or concurrent enrolment in another clinical study...
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
- Previous radiation therapy or surgery within 4 weeks of the randomization.
- Previous allogenic organ transplantation
- Previous anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapy
See the full eligibility criteria
- Radiologically or biopsy proven solitary HCC without biliary invasion or metastases, Liver Imaging Reporting and Data Systems (LI- RADS) 4 or 5 only. Participants with satellite tumour nodules are eligible.
- Tumour less than 12 cm in maximum size on CT or MRI.
- Planned surgical resection of HCC with a life expectancy of at least 12 weeks
- Age \>18 years at time of study entry.
- Child-Pugh Class A within 14 days prior to study enrollment
- Eastern Cooperative Oncology Group (ECOG) of 0 or 1 (see Appendix 3)
- Body weight \>30 kg at time of study enrollment
- Haemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC ≥1.0 × 109 /L)
- Platelet count ≥75 × 109/L
- Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN).
- AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal
- Creatinine CL (mL/min) = Weight (kg) x (140 - Age)72 x serum creatinine (mg/dL)
- Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
- Patient is capable and willing to provide signed informed consent.
- Previous therapy for HCC, including systemic therapy, surgery, radiation therapy, ablation or embolization.
- Participation in another clinical study with an investigational product during the last 4 weeks or concurrent enrolment in another clinical study, unless it is an observational (non-treatment) clinical study or during...
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Previous radiation therapy or surgery within 4 weeks of the randomization.
- Previous allogenic organ transplantation
- Previous anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapy
- Previous receipt of durvalumab and / or tremelimumab or allergy to it
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy except for alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician.
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician
- Patients with celiac disease controlled by diet alone
- History of active primary immunodeficiency
- Conditions that would preclude administration of durvalumab and / or tremelimumab
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial...
- Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening.
- b.1. Patients co-infected with HBV and HCV or co-infected with HBV and HDV, namely: HBV positive (presence of HBsAg and/or anti HBcAb with detectable HBV DNA); and
- b.2. HCV positive (presence of anti-HCV antibodies); or
- b.3. HDV positive (presence of anti-HDV antibodies)
- b.4. Patients with HBV infection, characterized by positive HBsAg and/or anti-HBcAb with undetectable HBV DNA (\< 10 IU/ml or under the limit of detection per local lab standard) do not require antiviral therapy prior...
- Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) which is not well controlled or active tuberculosis infection (clinical evaluation that may include clinical history...
- c.1. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA load for 3 months, CD4+ count of \>200 no history of AIDS-defining opportunistic infection...
- History of another primary malignancy, except for
- Malignancy treated with curative intent and with no known active disease ≥2 years before randomization and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to enrollment. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90 days after the last dose of IP.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab...
The study team makes the final eligibility decision.
Where it is enrolling
- Hamilton, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hamilton, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.