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A randomized, open label, controlled trial for Arsenic trioxide combined with Lenvatinib in the treatment of advanced unresectable hepatocellular carcinoma

A randomized, open label, controlled trial for Arsenic trioxide combined with Lenvatinib in the treatment of advanced unresectable hepatocellular carcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057630
Enrollment
Unknown
Registered
2022-03-15
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-10-30

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

Conditions

hepatocellular carcinoma

Interventions

Group 1 :Renvatinib
Group 2:Renvatinib + Arsenic Trioxide

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Regardless of gender, age >= 18 years; 2. Histological and cytological specimens were obtained and confirmed as primary hepatocellular carcinoma. Or meet the clinical diagnostic criteria in the "Norms for Primary Liver Cancer Diagnosis and Treatment 2019 Edition" issued by the Ministry of Health of China, and be diagnosed with primary liver cancer; 3. Pre-survival time >= 12 weeks; 4. Within 1 week prior to selection, the laboratory examination must meet the following conditions: (1) Neutrophil-leukocyte count (ANC) >= 1.5 x 10^9/L; (2) Platelet (BPC) >= 75 x 10^9/L; (3) Hemoglobin (Hgb) >= 80 g/L; (4) Alanine aminotransferase and aspartate aminotransferase (ALT and AST) = 50 mL/min); (7) No obvious abnormality in electrocardiogram; 5. General Condition Score (ECOG): 0,1 or 2; 6. No systemic therapy was received before enrollment, including systemic chemotherapy (oxaliplatin based chemotherapy) or targeted therapy (such as sorafenib).

Exclusion criteria

Exclusion criteria: 1. Receiving other anti-tumor treatments; 2. Severely infected or known to be infected with HIV; 3. Allergic to arsenic-containing drugs; 4. Known central nervous system tumors include metastatic brain diseases; 5. Severe renal insufficiency (serum creatinine > 200 ummol/L) or other serious organ diseases; 6. Pregnancy.

Design outcomes

Primary

MeasureTime frame
Progression free survival;

Secondary

MeasureTime frame
Overall survival;objective response rate;Serum drug resistance associated protein;Evaluation method of liver cancer related symptoms;Quality of life evaluation;Blood routine;liver function;coagulation function;urine and fecal routine;angiogenesis inhibitor;inflammatory factor;tumor markers;

Countries

China

Contacts

Public ContactXiaofeng Zhai

Shanghai Changhai Hospital

zhaixfch@163.com+86 21 81867840

Outcome results

None listed

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