Resectable Hepatocellular Carcinoma study: Ateganosine vs Cadonilimab
Official title THIO and Cadonilimab in Resectable Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT07446257
What this study is testing
What is ateganosine?
ateganosine is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for resectable hepatocellular carcinoma.
Also referred to as THIO, 6-thio-dG, 6-thio-2'-deoxyguanosine.
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
- The study aims to find out whether cadonilimab, alone or combined with ateganosine, works safely to treat resectable hepatocellular carcinoma.
- Who it's for
- Adults who have resectable hepatocellular carcinoma (liver cancer).
- What's involved
- Participants will receive cadonilimab by itself or together with ateganosine, and will have regular doctor visits and safety tests.
- Phase 1: an early, usually small safety 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
- Diagnosis of HCC confirmed by histology or according to the American Association for the Study of Liver Disease (AASLD) criteria a.
- HCC that is amenable to R0 resection with curative intent as determined by treating surgical/medical oncologists in consultation with the principal...
- Measurable disease according to RECIST 1.1
- No prior anti-PD (Programmed death)-1/L1 therapies for any indication
- Age ≥18
You likely can't join if
- Presence of extrahepatic extension of disease
- Prior locoregional therapy to target lesions is not allowed. History of curative locoregional therapy is allowed provided the following are met: 1)...
- Known fibrolamellar HCC or combined HCC-cholangiocarcinoma histology
- History of hepatic encephalopathy
- Severe ascites requiring paracentesis in the past 3 months
- people may not be receiving any other investigational agents for the treatment of the cancer under study
See the full eligibility criteria
- Diagnosis of HCC confirmed by histology or according to the American Association for the Study of Liver Disease (AASLD) criteria a.
- HCC that is amenable to R0 resection with curative intent as determined by treating surgical/medical oncologists in consultation with the principal investigator.
- Measurable disease according to RECIST 1.1
- No prior anti-PD (Programmed death)-1/L1 therapies for any indication
- Age ≥18
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Child Pugh A
- ANC (absolute neutrophil count) ≥ 1.5 x 109/L (does not apply to patients with benign ethnic neutropenia)
- Platelets ≥ 75 x 109/L without transfusion
- Hemoglobin ≥ 9 g/dL without transfusion within 2 weeks of screening
- ALT (Alanine Aminotransferase) ≤ 3 2 x ULN (Upper Limit of Normal)
- Bilirubin ≤ 3 x ULN
- Creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault formula using actual body weight
- All etiologies of chronic liver disease including but not limited to Hepatis C Virus (HCV) or Hepatis B Virus (HBV) infection.
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent.
- Willing and able to comply with the requirements and restrictions in this protocol.
- Presence of extrahepatic extension of disease
- Prior locoregional therapy to target lesions is not allowed. History of curative locoregional therapy is allowed provided the following are met: 1) previously treated tumor is not viable without evidence of residual...
- Known fibrolamellar HCC or combined HCC-cholangiocarcinoma histology
- History of hepatic encephalopathy
- Severe ascites requiring paracentesis in the past 3 months
- people may not be receiving any other investigational agents for the treatment of the cancer under study
- Prior significant bleeding event in the past 3 months that may pose a surgical risk
- History of trauma or major surgery within 28 days prior to the first dose of study drug administration.
- Autoimmune interstitial lung disease (lymphangitic spread of cancer is not disqualifying or stable/chronic lung disease that is not likely to be autoimmune in nature and progressive),
- Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of study drugs,
- Clinically significant cardiovascular disease,
- A condition that may obscure the interpretation of toxicity determination or AEs,
- History of prior bone marrow and/or solid-organ transplantation
- Hypersensitivity to IV contrast; not suitable for pre-medication
- Autoimmune diseases with only dermatologic involvement such as eczema, vitiligo, lichen chronicus, or resolved childhood asthma/atopy which involves less than 10% of the body surface area and symptoms are well...
- Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for thyroid, adrenal or pituitary insufficiency) is not considered a form of systemic treatment
- Participants with asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections will not be excluded from this study
- people with a condition requiring systemic treatment with either corticosteroids (\> 10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days of study administration.
- Prior malignancy that required systemic treatment within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer...
- Prisoners or people who are involuntarily incarcerated
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after contraception and until the termination of gestation, confirmed by a positive hCG (Human chorionic gonadotropin)...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Evidence of bleeding diathesis or significant coagulopathy
- Current use of full dose anticoagulant use which cannot be temporarily discontinued for surgery
- Receipt of live vaccinations within 30 days of first treatment day
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, United States
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 Dallas, Texas, United States. 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.