Clinical trial NCT06823050: A Prospective, Multicenter, Phase II Clinical Study on the Treatment of Unresectable Advanced HCC with DEB-TACE Combined with SALOX-HAIC
Official title: A Prospective, Multicenter, Phase II Clinical Study on the Treatment of Unresectable Advanced Hepatocellular Carcinoma with the DEB-TACE (drug-loaded Microsphere Transcatheter Arterial Chemoembolization) Combined with Hepatic Artery Perfusion of Raltitrexed and Oxaliplatin (SALOX-HAIC) Regimen
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatocellular Carcinoma
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: unresectable advanced HCC

Brief summary: The aim of this study is to clarify the safety and efficacy of DEB-TACE combined with SALOX-HAIC in the treatment of unresectable advanced primary liver cancer. To determine whether this therapy can prolong the indicators such as PFS, TTP, OS, ORR, and DOR.


Eligibility criteria: Inclusion Criteria:

* 1. Patient with unresectable HCC who strictly meet the clinical diagnostic criteria of the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) or who have been confirmed by histopathology or cytology, There was at least one measurable lesion (according to the requirements of mRECIST 1.1, the spiral CT scan diameter of the measurable lesion was ≥10mm or the short diameter of enlarged lymph node was ≥15mm).

  2. CNLC Ib-IIIa；BCLC：A-C 3. Patient age between 18 and 80，male or female. 4. ECOG 0-1. 5.Expected life span ≥ 3 months. 6. No history of severe comorbidities, such as hypertension, coronary heart disease, and mental illness, and no history of severe allergies.

  7. Child-Pugh A-B. 8.The laboratory tests meet the following requirements: platelets ≥ 50×109/L; hemoglobin ≥ 9g/dL; white blood cells ≥ 4×109/L; neutrophils ≥ 1.5×109/L; serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN), transaminases (ALT, AST) ≤ 5 times ULN; creatinine ≤ 1.5 times ULN; urine routine test shows that urine protein \< 2+; for patients whose urine routine test at baseline showed urine protein ≥ 2+, 24-hour urine collection should be conducted and the 24-hour urine protein quantification should be \< 1g; international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN.

  9. HBV DNA\<2000 IU/ml. 10. Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment.

  11. Patients sign informed consent, good compliance, cooperate with treatment.

Exclusion Criteria:

* 1. Imaging examinations were conducted for HCC patients with large liver tumors (≥60% of liver volume), or carcinoma thrombus in main portal vein (occupying ≥50% of vascular diameter), or carcinoma thrombus invading mesenteric vein or inferior vena cava, or significant arteriovenous/venous fistula.

  2. Before participating in this study, she had received local treatment such as TACE, external radiotherapy and radioactive particle implantation, and had undergone systemic chemotherapy, oral liver cancer targeting drugs (Sorafenib, Lenfacitinib, Apatinib) and immunotherapy such as PD-1/PD-L1/CDLA-4.

  3. Diffuse liver cancer patients. 4. Patients with grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450ms for men and 470ms for women.

  5. A history of gastrointestinal bleeding within the past 6 months or a definite tendency to gastrointestinal bleeding.

  6. Abnormal clotting function, bleeding tendency or receiving thrombolytic or anticoagulant therapy.

  7. Patients with central nervous system metastases or known brain metastases. Co-infected patients with HIV; Pregnant or lactating patients. Patients preparing for liver transplantation (other than those with previous liver transplantation.

  8. Systemic failure, estimated survival time \<3 months. 9. Severe renal dysfunction. 10. The patients could not complete the treatment plan due to various reasons, and lost control within three months after enrollment.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Time from the first DEB-TACE treatment to either radiological progression or death or up to 24 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Time Frame: Time from the first DEB-TACE treatment to death or up to 24 months
measure: Objective response rate (ORR)
timeFrame: 1, 3, 6,12,18,24 months after the first DEB-TACE treatment, up to death or 24 months, whichever came first.
measure: Disease control rate (DCR)
timeFrame: 1, 3, 6,12,18,24 months after the first DEB-TACE treatment, up to death or 24 months, whichever came first
measure: Time to Progression (TTP)
timeFrame: Time from the first DEB-BACE treatment to either radiological progression up to 24 months
Other outcomes:
Locations:
city: Deng zhou
country: China
facility: Deng zhou People's Hospital
state: Henan
city: Jiaozuo
country: China
facility: The Second People's Hospital of Jiaozuo
state: Henan
city: Kaifeng
country: China
facility: Huai He Hospital of Henan University
state: Henan
city: Luo Yang
country: China
facility: Luo Yang Central Hospital
state: Henan
city: Shangqiu
country: China
facility: First People's Hospital of Shangqiu
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhoukou
country: China
facility: Zhou Kou Central Hospital
state: Henan
Study officials:
References: