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A prospective randomized control study of hepatic metastasis of colonic carcinoma by TACE/TAC

A prospective randomized control study of hepatic metastasis of colonic carcinoma by TACE/TAC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004974
Enrollment
Unknown
Registered
2014-07-19
Start date
2014-08-01
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

hepatic metastasis of colonic carcinoma

Interventions

Sponsors

Xinqiao Hospital of Third Military Medical University, Chongqing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Must have histologically (cytological) confirmed hepatic metastasis of colonic carcinoma (Primary tumor has been surgically removed); 2. To be aged 18 to 75 years old; 3. Must have a life expectancy at least 90 days; 4. KPS score more than 70; 5. Must at least have one measurable or evaluable tumor observation index, if within the field of radiation, radiotherapy must be discontinued for 2 months; 6. Must have completed any previous cancer surgery or radiotherapy at least 30 days before the clinical study; 7. Must not have previously received systemic chemotherapy; 8. Peripheral blood picture: WBC more than 4000/ul, PLT more than 100000/ul; 9. Renal function test: Cr more than 1.3mg/dl, BUN less than 1.25*N; 11. Liver function test: STB less than 2.0mg/dl, ALT less than 2.4*N, AST less than 2.5*N, AKP less than 2.5*N; 10. Must have good compliance; 11. Must give written informed consent prior to treatment.

Exclusion criteria

Exclusion criteria: 1. Patient who is participating in other pharmaceutical study; 2. Patient with other uncured cancer (s), other than colonic carcinoma; 3. Patient needing concomitant therapy (surgery, radiotherapy, etc.) while on study; 4. Patient with acute bacteria or virus infection; 5. Patient with severe, uncontrolled medical disease(s); 6. Patient with active brain metastasis; 7. Patient with obvious abnormal vital sign and heart, liver & renal function; 8. Patient who has a known allergy to test drug or its components; 9. Patient who is pregnant or lactating; 10. Patient with uncontrolled epilepsy and central nervous system disease(s); 11. Patient with only unmeasurable lesions such as cancerous pleural effusion, ascites, bone metastasis and meninges, etc.

Design outcomes

Primary

MeasureTime frame
survival time;PFS;radiographic parameters;progress free survival;

Countries

China

Contacts

Public ContactHuang Xiaobing
huang-x-b@163.com+86 13372618116

Outcome results

None listed

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