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New treatment option for Hepatocellular Carcinoma
Official title Durvalumab and Tremelimumab in Resectable HCC
ClinicalTrials.gov ID: NCT05440864
What this study is testing
What is Tremelimumab?
Tremelimumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma.
Also referred to as Durvalumab.
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
- Hepatocellular Carcinoma (HCC) is the third most common cause of death from cancer world wide and the incidence is rising globally. Despite surgical resection in appropriate patients, many patients recur.
- Phase 2: a mid-size study of how well it works
- 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
- For inclusion in the study, patients should fulfil the following criteria at time of study enrolment or when indicated:
- Patient must be capable of providing written informed consent.
- Age \>18 years at time of study entry
- Histologically proven resectable HCC (early and intermediate stage HCC)\
- Must consent to provide biopsy sample prior to treatment
You likely can't join if
- 1\. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. 2\. Any prior therapy for HCC - except liver resection or ablation...
- Prostate cancer of pathologic stage less than or equal to T2cN0M0 determined from a prior prostatectomy without biochemical recurrence and who, in...
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study treatment and of low potential risk...
- Adequately treated non-melanoma skin cancer or lentigo malignant without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease 12. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer...
See the full eligibility criteria
- For inclusion in the study, patients should fulfil the following criteria at time of study enrolment or when indicated:
- Patient must be capable of providing written informed consent.
- Age \>18 years at time of study entry
- Histologically proven resectable HCC (early and intermediate stage HCC)\
- Must consent to provide biopsy sample prior to treatment
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Childs Pugh score of 5 or 6
- ALBI grade 1†
- Patients with HBV infection, which is characterized by positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibodies (anti-HBcAb) with detectable HBV DNA (≥10 IU/ml or above the limit of detection per...
- Patients with HCV infection must have management of this disease per local institutional practice throughout the study. HCV diagnosis is characterized by the presence of detectable HCV ribonucleic acid (RNA) or anti-HCV...
- Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients.
- Female of childbearing potential and non-sterilized male partners of a female patient of childbearing potential must agree to use effective method of contraception from the time of screening throughout the total...
- Adequate normal organ and marrow function as defined below within screening period:
- Haemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC ≥1.0 × 109 /L)
- Platelet count ≥65 × 109/L
- Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). \<\<This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in...
- AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal
- Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine clearance CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine...
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Body weight \> 30kg
- 1\. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. 2\. Any prior therapy for HCC - except liver resection or ablation on one occasion only which was given with curative intent and that...
- Prostate cancer of pathologic stage less than or equal to T2cN0M0 determined from a prior prostatectomy without biochemical recurrence and who, in the opinion of the Investigator, are not deemed to require active...
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study treatment and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo malignant without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease 12. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
- Milan, Italy
- Pamplona, Spain
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include Toronto, Ontario, Canada; Milan, Italy; Pamplona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.