NCT07446257

Brief 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
61mo left

Started May 2026

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2031

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

January 29, 2026

Last Update Submit

February 25, 2026

Conditions

Resectable Hepatocellular Carcinoma

Keywords

liverhepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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)

    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

    Day 1 of treatment up to surgery resection

  • Radiographic response after ateganosine plus cadonilimab

    Baseline to between day 2-4 of the last cycle immediately prior to surgery

  • Survival outcomes after ateganosine plus cadonilimab

    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]

    post last dose visit up to 3 years until death, loss to follow-up, or until study termination by the Sponsor.

Study Arms (3)

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

Drug: ateganosineDrug: Cadonilimab

Arm B: Ateganocine

EXPERIMENTAL

Ateganosine: 60 mg/day (180 mg/cycle) IV over 30 minutes±5 minutes

Drug: ateganosine

Arm C: Cadonilimab

EXPERIMENTAL

Cadonilimab: 10 mg/kg IV over 60 minutes±5 minutes

Drug: Cadonilimab

Interventions

ateganosineDRUG

ateganosine: 180 mg IV D1, D2, D3 of 21-day cycle

Also known as: THIO, 6-thio-dG, 6-thio-2'-deoxyguanosine
Arm A: Ateganocine + CadonilimabArm B: Ateganocine
CadonilimabDRUG

cadonilimab: 10 mg/kg IV D5 of 21-day cycle

Also known as: AK104 (or AK-104)
Arm A: Ateganocine + CadonilimabArm C: Cadonilimab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of HCC confirmed by histology or according to the American Association for the Study of Liver Disease (AASLD) criteria
  • a. 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
  • 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
  • +7 more criteria

You may not qualify 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) 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
  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

alpha-2'-deoxythioguanosine

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Carrie Manwaring

CONTACT

214-648-7097carrie.manwaring@utsouthwestern.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOC PROFESSOR • Internal Medicine

Study Record Dates

First Submitted

January 29, 2026

First Posted

March 3, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2031

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)