Sequential T and I With H101 Via HAI for BCLC C Stage HCC: A Prospective Single-Center Single-Arm… (NCT06685354) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sequential T and I With H101 Via HAI for BCLC C Stage HCC: A Prospective Single-Center Single-Arm Pilot Study
China11 participantsStarted 2024-11
Plain-language summary
Indication: Hepatocellular carcinoma (HCC) patients at Barcelona Clinic Liver Cancer (BCLC) stage C.
Study Objectives: This study aims to use a prospective single-center single-arm pilot approach to preliminarily obtain data on the recent efficacy and safety of sequential targeted and immunotherapy with recombinant human type 5 adenovirus (H101) administered via hepatic arterial infusion for BCLC stage C HCC. Additionally, it will explore changes in the patients\' immune systems before and after treatment, providing a basis for formal research.
Study Content: The study will use a prospective single-center single-arm pilot design to preliminarily assess the efficacy of sequential targeted and immunotherapy with H101 via hepatic arterial infusion in BCLC stage C HCC. Primary efficacy endpoints include: Objective Response Rate (ORR). Secondary efficacy endpoints include: Disease Control Rate (DCR), Duration of Response (DOR), Progression-Free Survival (PFS) at 6 months and 12 months, Overall Survival (OS) at 6 months and 12 months, Median Progression-Free Survival (mPFS), Liver-specific PFS. Additionally, the study will collect data on safety and tolerability and will explore changes in peripheral blood lymphocytes before and after treatment.
Expected Objectives: Efficacy and Safety Assessment: To preliminarily gather data on the short-term efficacy, safety, and tolerability of sequential targeted and immunotherapy using hepatic arterial infusion of H101 in patients with BCLC stage C HCC. This includes assessing primary efficacy endpoints (e.g., objective response rate) and secondary efficacy endpoints (e.g., disease control rate, duration of response, progression-free survival, overall survival, etc.). Immune System Changes: To investigate the patterns of peripheral blood lymphocyte changes before and after treatment.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Voluntarily participating in the study, signing the informed consent form, and willing to undergo follow-up;
✓. Age ≥ 18 years and ≤ 75 years, regardless of gender;
✓. Clinically or pathologically confirmed BCLC Stage C hepatocellular carcinoma, with no prior TACE or systemic treatment;
✓. Baseline imaging (MRI or CT) showing measurable lesions with a longest diameter ≥ 1 cm;
✓. Child-Pugh score ≤ 7 (Child-Pugh A-B);
✓. Liver tumor burden not exceeding 50% of the liver volume;
✓. Able to swallow pills normally;
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 (see Appendix 1 for ECOG PS scoring);
Exclusion criteria
✕. Significant clinical bleeding symptoms or clear gastrointestinal bleeding tendencies (e.g., severe esophageal or gastric varices, active gastrointestinal ulcers, or vasculitis) within 3 months before enrollment. If fecal occult blood is positive during screening, a recheck is required, and if still positive, gastroscopy must be performed.
What they're measuring
1
Objective response rate (ORR)
Timeframe: Generally, the ORR is assessed for each participant every two treatment cycles(each cycle is 3 weeks).
✕. Active autoimmune diseases or history of autoimmune diseases with potential for recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, and hypothyroidism - only subjects controlled by hormone replacement therapy are allowed). Subjects with skin conditions requiring no systemic treatment (e.g., vitiligo, psoriasis, alopecia), childhood asthma fully resolved, and no intervention needed in adulthood may be included. Asthma patients requiring bronchodilators for medical intervention cannot be included.
✕. Use of immunosuppressants or systemic steroids within 2 weeks before enrollment for immunosuppressive purposes (dose \>10mg/day of prednisone or equivalent).
✕. Allergy to any monoclonal antibodies, anti-angiogenesis targeted drugs, or excipients.
✕. Known history of central nervous system metastases or hepatic encephalopathy.
✕. Patients who are preparing for or have previously received organ or allogeneic bone marrow transplants.
✕. Ascites with clinical symptoms requiring paracentesis or drainage, or ascites that has been drained within the past 3 months. Excludes asymptomatic ascites with minimal amounts seen on imaging.
✕. Uncontrolled hypertension despite antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) (average of ≥2 measurements). Previous hypertension crisis or hypertensive encephalopathy.