A Prospective, Multicenter, Phase II Clinical Study on the Treatment of Unresectable Advanced HCC with DEB-TACE Combined with SALOX-HAIC

NCT06823050 | Not Yet Recruiting

• 1 other identifier: 2025-KY-0112-001
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 7

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Time from the first DEB-TACE treatment to either radiological progression or death or up to 24 months

Secondary Outcomes (4)

• Overall survival (OS)

  Time Frame: Time from the first DEB-TACE treatment to death or up to 24 months

• Objective response rate (ORR)

  1, 3, 6,12,18,24 months after the first DEB-TACE treatment, up to death or 24 months, whichever came first.

• Disease control rate (DCR)

  1, 3, 6,12,18,24 months after the first DEB-TACE treatment, up to death or 24 months, whichever came first

• Time to Progression (TTP)

  Time from the first DEB-BACE treatment to either radiological progression up to 24 months

Study Arms (1)

DEB-TACE+ SALOX-HAIC+Apatinib+Carilizumab

Drug-eluting bead transarterial chemoembolization combined with SALOX-HAIC sequential Apatinib and Carilizumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

unresectable advanced HCC

You may qualify if:

• \. 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).
• \. 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.
• \. 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.
• \. HBV DNA\<2000 IU/ml. 10. Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment.
• \. Patients sign informed consent, good compliance, cooperate with treatment.

You may not qualify if:

• \. 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.
• \. 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.
• \. 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.
• \. A history of gastrointestinal bleeding within the past 6 months or a definite tendency to gastrointestinal bleeding.
• \. Abnormal clotting function, bleeding tendency or receiving thrombolytic or anticoagulant therapy.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Xuhua Duan: lead

Study Sites (7)

Deng zhou People's Hospital

Dengzhou, Henan, China

Location

The Second People's Hospital of Jiaozuo

Jiaozuo, Henan, China

Location

Huai He Hospital of Henan University

Kaifeng, Henan, China

Location

Luo Yang Central Hospital

Luoyang, Henan, China

Location

First People's Hospital of Shangqiu

Shangqiu, Henan, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Zhou Kou Central Hospital

Zhoukou, Henan, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Hua Xu Xuhua Duan

CONTACT

13523402912; xuhuaduan@163.com

Xinwei Han

CONTACT

13803842129; zzudxh@yeah.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 12, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): February 28, 2028
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

CN (7)