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The clinical randomized trial of adjuvant chemotherapy with FOLFOX to reduce the recurrence in HCC patients at high risk after resection

The clinical randomized trial of adjuvant chemotherapy with FOLFOX to reduce the recurrence in HCC patients at high risk after resection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15007509
Enrollment
Unknown
Registered
2015-12-03
Start date
2015-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Hepatocellular carcinoma

Interventions

FOLFOX therapy group:Adjuvant therapy 8~12 cycles with FOLFOX

Sponsors

Cancer Center of SUN Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18~75 years; 2. ECOG PS score =1.5*10^9/L; (2) Hemoglobin >=90g/L; (3) Platelet count >=75*10^9/L; (4) Serum albumin >=35g/L; (5) Serum total bilirubin <=1.5*ULN (upper limit of normal); (6) Serum AST and ALT <2.5*ULN; (7) Serum creatinine <=1.5*ULN; (8) INR <=1.5; 9. Give signed informed consent before enrollment.

Exclusion criteria

Exclusion criteria: 1. Function impairment of vital organs (heart, lung, kidney, etc), serious infection or >grade 2 adverse events (CTCAE Version 3.0); 2. Histologically confirmed of positive resection margin (R1 resection); 3. Previous or current malignant tumor beyond HCC; 4. Allergy to any agent of the FOLFOX regimen; 5. History of organ transplantation; 6. Previously receiving other treatments for HCC; 7. Pregnant or breastfeeding women, and women of childbearing potential without adequate contraception; 8. Neurological or mental abnormalities that may affect cognitive assessment and inform consent; 9. Concomitant anti-tumor therapy or participating in other interventional clinical trials 10. Other psychological, family or social reason, which would affect compliance with the study protocol.

Design outcomes

Primary

MeasureTime frame
Disease-free survival;

Secondary

MeasureTime frame
Recurrence rate;Overall survival;Safety profile;

Countries

China

Contacts

Public ContactGuo Rongping
guorp@sysucc.org.cn+86 18819809988

Outcome results

None listed

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