Is NCT07446257 recruiting in Dallas, TX?

Yes, NCT07446257 is currently enrolling participants at its Dallas, TX location. This resectable hepatocellular carcinoma clinical trial is accepting qualified participants.

Is participation in this Dallas clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Resectable Hepatocellular Carcinoma Clinical Trial in Dallas, TX

Q: How do I join the resectable hepatocellular carcinoma clinical trial in Dallas?

To join this clinical trial in Dallas, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Who Can Participate

Inclusion Criteria

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

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.

Exclusion Criteria

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

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Dallas?

Yes, this clinical trial (NCT07446257) has an active research site in Dallas, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Resectable Hepatocellular Carcinoma Treatment Options in Dallas, TX

If you're searching for resectable hepatocellular carcinoma treatment options in Dallas, TX, this clinical trial (NCT07446257) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Dallas research site is actively enrolling participants for this early phase 1 clinical trial. You'll receive care from experienced resectable hepatocellular carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all resectable hepatocellular carcinoma clinical trials near you to find additional studies recruiting in your area.

Resectable Hepatocellular Carcinoma Clinical Trial in Dallas, TX

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