A prospective, randomized, controlled trial comparing adjuvant therapy after hepatectomy and pure hepatectomy in colorectal cancer liver metastasis patients with low-risk of recurrence

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000037406

Enrollment

Unknown

Registered

2020-08-28

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-10-13

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

Conditions

colorectal cancer liver metastasis

Interventions

adjuvant therapy group:Adjuvant chemotherapy FOLFOX, CapeOX, or Xeloda single drug

control group:none

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged>=18 years old; 2. A pathologically confirmed patient with liver metastasis from colorectal cancer; 3. R0 excision of primary and liver metastases; 4. CRS score 2-0; 5. No extrahepatic metastases; 6. Within 30 days after liver surgery; 7. Adequate liver function is present; 8. ECOG PS score 0-1; 9. Baseline blood routine and blood biochemical indicators shall meet the following standards: 90 g/L or higher hemoglobin, absolute neutrophil count acuity 1.5 x 10^9/ L, the platelet count 75 x 10^12/L or higher; Aspartic acid or alanine aminotransferase =30g/L; Serum creatinine < 1.5 ULN;The international standard ratio (INR) <=2 or the prothrombin time (PT) exceeds the upper limit of the normal range <=6 seconds; 10. Before entering the study, the researcher assessed that it was appropriate to participate in the study; 11. Male and female subjects with potential fertility must agree to use effective contraceptive methods throughout the study period; 12. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Primary and liver metastases cannot reach R0 resection, or extrahepatic metastases exist; 2. Previous allergic reactions to oxaliplatin, 5-Fu, capecitabine and other drugs; 3. Pregnant or lactating patients; 4. Previously uncured patients with other malignant tumors; 5. Immunodeficiency patients, such as HIV positive; History of organ transplantation; Suffering from uncontrollable mental illness; 6. Other factors led the researcher to consider it inappropriate to participate in this study.

Design outcomes

Primary

Measure	Time frame
overall survival;	—

Secondary

Measure	Time frame
Disease Free Survival;	—

Countries

China

Contacts

Public ContactJiamin Zhou

Shanghai Cancer Center, Fudan University

zhoujiamin0514@aliyun.com+86 18121299408

Outcome results

None listed

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