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Lenvatinib Combined with Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin in Patients with Intermediate-Stage Hepatocellular Carcinoma Beyond Up-To-Seven Criteria: a Phase II, Single-arm, Prospective Study

Lenvatinib Combined with Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin in Patients with Intermediate-Stage Hepatocellular Carcinoma Beyond Up-To-Seven Criteria: a Phase II, Single-arm, Prospective Study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045241
Enrollment
Unknown
Registered
2021-04-09
Start date
2021-04-15
Completion date
Unknown
Last updated
2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Interventions

Experimental group:Lenvatinib combined with Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin

Sponsors

Guangdong Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. 18 years or older. 2. HCC was diagnosed according to the American Association for the Study of Liver Diseases (AASLD) criteria. 3. No prior treatment for HCC. 4. At least one measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). 5. Classified as stage B according to the Barcelona Clinic Liver Cancer (BCLC) staging system. 6. The tumor exceeds the Up-To-Seven criteria, that is, the sum of the number of tumors and the maximum tumor long diameter (cm) is greater than 7. 7. Child-Pugh score A. 8. Performance status (PS) ECOG score 0. 9. Adequate organ function, defined as: WBC >= 3.0 x 10 ^ 9/L; Neu >= 1.5 x 10 ^ 9/L; Hb >= 8.5 g/dL; PLT >= 75 x 10 ^ 9/L; OALB >= 2.8 g/dL; TBIL <= 3.0 mg/dL; AST and ALT <= 5 times the upper limit of normal; Cre <= 1.5 x upper limit of normal. 10. Subjects voluntarily participate in this study, and sign the informed consent form, cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Other invasive malignant diseases. 2. Patients with gastrointestinal bleeding within 28 days prior to study participation. 3. Gastric or esophageal varices requiring interventional therapy within 28 days prior to study participation. 4. Known or suspected allergy to lenvatinib, 5-fluorouracil, oxaliplatin, calcium folinate/ calcium levofolinate or iodine contrast agent. 5. Human immunodeficiency virus (HIV) positive or active infection requiring treatment (except hepatitis virus). 6. Major surgery within 3 weeks prior to study participation. 7. Having undergone liver transplantation. 8. Patients who are pregnant or lactating.

Design outcomes

Primary

MeasureTime frame
Objective response rate;—

Secondary

MeasureTime frame
Progression-free survival;Overall Survival;—

Countries

China

Contacts

Public ContactChen Xiaoming

Guangdong Provincial People's Hospital

chenxiaom1962@126.com+86 13902497476

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026