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A Phase III Randomized Controlled Trial of Comparison of Survival Benefit of Hepatic Arterial Infusion of Oxaliplatin plus Raltitrexed With Sorafenib for Patients With intermediate- and advanced-stage Hepatocellular Carcinoma

A Phase III Randomized Controlled Trial of Comparison of Survival Benefit of Hepatic Arterial Infusion of Oxaliplatin plus Raltitrexed With Sorafenib for Patients With intermediate- and advanced-stage Hepatocellular Carcinoma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032992
Enrollment
Unknown
Registered
2020-05-17
Start date
2020-05-20
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

Hepatocellular carcinoma

Interventions

A:Hepatic Arterial Infusion of Oxaliplatin plus Raltitrexed
B:Oral sorafenib

Sponsors

Fujian Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. For the patients with primary liver cancer, the diagnosis standard is the standard set in the national health and Health Commission's "primary liver cancer diagnosis and treatment standard (2019 version)"; the BCLC stage standard is used for the stage; 2. The patients included shall be: (1) BCLC stage C patients who are not suitable for conventional TACE; (2) In BCLC stage B patients with multiple intrahepatic lesions or significant arteriovenous fistulas, conventional chemoembolization was ineffective; 3. Patients who have received local treatment before, such as surgery, TACE, RFA, radiotherapy, can be included in the study, and the pre-treatment should be stopped for more than 4 weeks; 4. Patients between 18-70 years old; 5. Bone marrow function (HB >=10 g/dl, WBC >=3000/uL, platelet count >=75000/uL), liver function (bilirubin <=3 mg / dl, transaminase <=200 U/L), kidney function (myoliver <=390 umol/L). Coagulation function was normal; 6. Patients with ECoG score of 0-2; 7. Patients willing to sign informed consent; 8. Patients willing to cooperate with regular follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with decompensated liver function (including uncontrolled ascites, hepatic encephalopathy, acute or recent gastrointestinal bleeding within 2 weeks); 2. Patients with active infection; 3. Pregnant or lactating women; 4. Patients with serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc; 5. Patients with expected survival less than 3 months; 6. Patients with extrahepatic metastasis.

Design outcomes

Primary

MeasureTime frame
Tumor response;overall survival;

Countries

China

Contacts

Public ContactWenchang Yu

Fujian Cancer Hospital

a357083291@163.com+86 13599962209

Outcome results

None listed

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