Resectable Hepatocellular CarcinomaEarly Phase 1NCT07446257
THIO and Cadonilimab in Resectable Hepatocellular Carcinoma
A Early Phase 1 study testing ateganosine and Cadonilimab in people with Resectable Hepatocellular Carcinoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The goal of this clinical study is to find out if cadonilimab or ateganosine plus cadonilimab is effective and safe in treating resectable hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Hepatocellular Carcinoma
- What is being tested?
- ateganosine and Cadonilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Sep 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of HCC confirmed by histology or according to the American Association for the Study of Liver Disease (AASLD) criteria
- Availability of tumor tissue samples prior to the first day of study treatment is required for all patients.
- HCC that is amenable to R0 resection with curative intent as determined by treating surgical/medical oncologists in consultation with the principal investigator. Subject must be a suitable candidate for surgery based on evaluations by the treating surgeon/oncologist.
- Measurable disease according to RECIST 1.1
- No prior anti-PD (Programmed death)-1/L1 therapies for any indication
- Age ≥18
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- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Child Pugh A
- Adequate organ and marrow function as defined below:
- 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. HCV and HBV infection status does not preclude eligibility as long as patients meet all other eligibility criteria but must be known prior to starting treatment. Patients with HBV must be on anti-viral therapy prior to the first day of investigational drug treatment. Patients with HCV may include active or resolved infection.
- All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months following the last dose of ateganosine or 4 months following the last dose of cadonilimab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- 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.
Who cannot join
- 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 disease for at least 12 months, and 2) patient has not received local therapy in the past 12 months.
- Known fibrolamellar HCC or combined HCC-cholangiocarcinoma histology
- History of hepatic encephalopathy
- Severe ascites requiring paracentesis in the past 3 months
- Subjects may not be receiving any other investigational agents for the treatment of the cancer under study
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- 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. (Tumor biopsy or placement of central venous access catheter (eg, port or similar) is not considered a major surgical procedure)
- Underlying medical conditions that, in the investigator's opinion, will make the administration of study drugs hazardous, including but not limited to:
- 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
- Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past year (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), with the following exceptions:
- 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 controlled on topical treatments without recent exacerbations requiring other therapies
- 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
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days of study administration. Inhaled or topical steroids and adrenal replacement doses ≤10 mg/day prednisone equivalents are permitted in the absence of autoimmune disease.
- 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, or carcinoma in situ of the cervix, breast, or prostate cancer. Patients with a cancer history with a low risk of recurrence or progression may be enrolled as determined by the principal investigator.
- Prisoners or subjects 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) laboratory test
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Carrie Manwaring, 214-648-7097, carrie.manwaring@utsouthwestern.edu
David Hsieh, MD
About this study
Official title: A Phase Ib Open-label, Randomized Trial Evaluating Neoadjuvant Ateganosine and Cadonilimab in Resectable Hepatocellular Carcinoma
The goal of this clinical study is to find out if cadonilimab or ateganosine plus cadonilimab is effective and safe in treating resectable hepatocellular carcinoma (HCC).
Read the detailed description
In this study, ateganosine (also know as THIO, 6-thio-dG, 6-thio-2'-deoxyguanosine) and cadonilimab are given via intravenous infusion. The participant will be randomly assigned to receive cadonilimab alone, ateganosine alone, or ateganosine and cadonilimab.
For this study, a cycle is defined as 21 calendar days during which drugs are administered.
If the participant is randomized to the cadonilimab alone arm, infusions will be given on the first day of every 21-day cycle. The participant will receive 2 doses of cadonilimab and then be evaluated for surgery.
If the participant is randomized to be treated with ateganosine alone, infusions of ateganosine will be given on days 1 to 3 of every 21-day cycle for 3 cycles and then the participant will be evaluated for surgery.
If the participant is randomized to be treated with ateganosine and cadonilimab, infusions of ateganosine will be given on days 1 to 3 of every 21-day cycle for 3 cycles. Infusions of cadonilimab will be given on day 5 of every 21-day cycle for 2 cycles. After receiving 3 cycles of ateganosine and 2 cycles of cadonilimab, the participant will be evaluated for surgery.
- Conditions
- Resectable Hepatocellular Carcinoma
- Being tested
- ateganosine, Cadonilimab
- Keywords
- liver, hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ateganosineDrug
Also called THIO, 6-thio-dG, 6-thio-2'-deoxyguanosine
ateganosine: 180 mg IV D1, D2, D3 of 21-day cycle
CadonilimabDrug
Also called AK104 (or AK-104)
cadonilimab: 10 mg/kg IV D5 of 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Ateganocine + Cadonilimab | Experimental | Ateganosine: 60 mg/day (180 mg/cycle) IV over 30 minutes±5 minutes Cadonilimab: 10 mg/kg IV over 60 minutes±5 minutes Receives: Drug: ateganosine; Drug: Cadonilimab |
| Arm B: Ateganocine | Experimental | Ateganosine: 60 mg/day (180 mg/cycle) IV over 30 minutes±5 minutes Receives: Drug: ateganosine |
| Arm C: Cadonilimab | Experimental | Cadonilimab: 10 mg/kg IV over 60 minutes±5 minutes Receives: Drug: Cadonilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related delay of surgical resection >28 days from expected surgery date.
Safety is measured as the proportion of participants who experience a treatment-related delay in the planned surgical resection, defined as surgery occurring more than 28 days after the expected surgery date (day 5 of cycle 3 for all treatment arms)
Measured: 28 days after the expected surgery date (day 5 of cycle 3 for all treatment arms)
Secondary outcomes (4)
Pathologic response of ateganosine plus cadonilimab
Response will be determined by pathology review of resection specimens and will be based on <30% residual viable tumor in the tumor bed at the time of surgery.
Measured: Day 1 of treatment up to surgery resection
Radiographic response after ateganosine plus cadonilimab
Radiographic response will be based on changes in only the largest diameter (unidimensional measurement) of the tumor lesions per the RECIST v1.1 criteria.
Measured: Baseline to between day 2-4 of the last cycle immediately prior to surgery
Survival outcomes after ateganosine plus cadonilimab
Overall survival (measured as time from the first dose of study treatment to death from any cause)
Measured: first dose of drug (whichever was last) up to 36 months until death, loss to follow-up, or until study termination by the Sponsor.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of treatment emergent adverse events (AEs), immune-related AEs, and serious AEs (Grade ≥3 per Common Terminology Criteria for Adverse Events, CTCAE v5.0).
Measured: post last dose visit up to 3 years until death, loss to follow-up, or until study termination by the Sponsor.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Sep 2026
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maia Biotechnology, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, David Hsieh, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446257
- Sponsor's protocol ID
- SCCC-12225; STU20251351
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Open-label, Randomized Trial Evaluating Neoadjuvant Ateganosine and Cadonilimab in Resectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07446257
- Acronym / sponsor ID
- SCCC-12225; STU20251351
- Conditions
- Resectable Hepatocellular Carcinoma
- Keywords
- liver, hepatocellular carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Maia Biotechnology, National Cancer Institute (NCI)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to find out if cadonilimab or ateganosine plus cadonilimab is effective and safe in treating resectable hepatocellular carcinoma (HCC).
Detailed description
In this study, ateganosine (also know as THIO, 6-thio-dG, 6-thio-2'-deoxyguanosine) and cadonilimab are given via intravenous infusion. The participant will be randomly assigned to receive cadonilimab alone, ateganosine alone, or ateganosine and cadonilimab.
For this study, a cycle is defined as 21 calendar days during which drugs are administered.
If the participant is randomized to the cadonilimab alone arm, infusions will be given on the first day of every 21-day cycle. The participant will receive 2 doses of cadonilimab and then be evaluated for surgery.
If the participant is randomized to be treated with ateganosine alone, infusions of ateganosine will be given on days 1 to 3 of every 21-day cycle for 3 cycles and then the participant will be evaluated for surgery.
If the participant is randomized to be treated with ateganosine and cadonilimab, infusions of ateganosine will be given on days 1 to 3 of every 21-day cycle for 3 cycles. Infusions of cadonilimab will be given on day 5 of every 21-day cycle for 2 cycles. After receiving 3 cycles of ateganosine and 2 cycles of cadonilimab, the participant will be evaluated for surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Ateganocine + Cadonilimab | Experimental | Drug: ateganosine, Drug: CadonilimabAteganosine: 60 mg/day (180 mg/cycle) IV over 30 minutes±5 minutes Cadonilimab: 10 mg/kg IV over 60 minutes±5 minutes |
| Arm B: Ateganocine | Experimental | Drug: ateganosineAteganosine: 60 mg/day (180 mg/cycle) IV over 30 minutes±5 minutes |
| Arm C: Cadonilimab | Experimental | Drug: CadonilimabCadonilimab: 10 mg/kg IV over 60 minutes±5 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Diagnosis of HCC confirmed by histology or according to the American Association for the Study of Liver Disease (AASLD) criteria
- HCC that is amenable to R0 resection with curative intent as determined by treating surgical/medical oncologists in consultation with the principal investigator. Subject must be a suitable candidate for surgery based on evaluations by the treating surgeon/oncologist.
- Measurable disease according to RECIST 1.1
- No prior anti-PD (Programmed death)-1/L1 therapies for any indication
- Age ≥18
Key exclusion criteria (27 listed)
- 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 disease for at least 12 months, and 2) patient has not received local therapy in the past 12 months.
- Known fibrolamellar HCC or combined HCC-cholangiocarcinoma histology
- History of hepatic encephalopathy
- Severe ascites requiring paracentesis in the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ateganosineAlso: THIO, 6-thio-dG, 6-thio-2'-deoxyguanosineateganosine: 180 mg IV D1, D2, D3 of 21-day cycle | Drug | Arm A: Ateganocine + Cadonilimab, Arm B: Ateganocine |
| CadonilimabAlso: AK104 (or AK-104)cadonilimab: 10 mg/kg IV D5 of 21-day cycle | Drug | Arm A: Ateganocine + Cadonilimab, Arm C: Cadonilimab |
Primary outcome
Incidence of treatment-related delay of surgical resection >28 days from expected surgery date.
Time frame: 28 days after the expected surgery date (day 5 of cycle 3 for all treatment arms)
Safety is measured as the proportion of participants who experience a treatment-related delay in the planned surgical resection, defined as surgery occurring more than 28 days after the expected surgery date (day 5 of cycle 3 for all treatment arms)
4 secondary outcomes
Pathologic response of ateganosine plus cadonilimab
Time frame: Day 1 of treatment up to surgery resection
Radiographic response after ateganosine plus cadonilimab
Time frame: Baseline to between day 2-4 of the last cycle immediately prior to surgery
Survival outcomes after ateganosine plus cadonilimab
Time frame: first dose of drug (whichever was last) up to 36 months until death, loss to follow-up, or until study termination by the Sponsor.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: post last dose visit up to 3 years until death, loss to follow-up, or until study termination by the Sponsor.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ateganosine and Cadonilimab in people with Resectable Hepatocellular Carcinoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carrie Manwaring (214-648-7097, carrie.manwaring@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related delay of surgical resection >28 days from expected surgery date. (time frame: 28 days after the expected surgery date (day 5 of cycle 3 for all treatment arms)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.