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A prospective, multicenter, randomized controlled clinical trial of preoperative regional arterial infusion chemotherapy and systemic intravenous chemotherapy for locally advanced colorectal cancer

A prospective, multicenter, randomized controlled clinical trial of preoperative regional arterial infusion chemotherapy and systemic intravenous chemotherapy for locally advanced colorectal cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039431
Enrollment
Unknown
Registered
2020-10-28
Start date
2020-11-01
Completion date
Unknown
Last updated
2021-02-01

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

Conditions

colorectal cancer

Interventions

Control Group (A Group):Systemic intra-venous chemotherapy
Experimental group (B Group):Regional arterial perfusion chemotherapy

Sponsors

The Third Affiliated Hospital affiliated to Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 20 and = 70, ECOG physical status score.

Exclusion criteria

Exclusion criteria: 1. Middle and low rectal cancer (distance from anus <= 12cm); 2. Familial adenomatous polyposis, Lynch syndrome and other hereditary colorectal cancers; 3. Preoperative imaging indicated distant organ metastasis, such as liver metastasis, lung metastasis, etc. 4. Patients with tumor complicated with acute ileus, perforation or bleeding, or requiring emergency surgery; 5. Patients with other malignant diseases or with other malignant diseases within 5 years, or with other diseases requiring simultaneous surgery; 6. A history of continuous systemic corticosteroid or immunosuppressive drug therapy within 1 month; 7. Expected survival less than 6 months; 8. Imaging examination or interventional catheter contrast allergy; 9. Severe heart, brain, liver, lung, kidney, hematopoietic system and other important organ diseases or functional insufficiency, unable to tolerate chemotherapy, intervention or surgery.

Design outcomes

Primary

MeasureTime frame
downstaging rate;

Secondary

MeasureTime frame
disease control rate;pathologic complete response;R0 resection rates;complication;1 and 3-year overall survival;1 and 3-year disease free survival rate;1 and 3-year recurrence pattern;

Countries

China

Contacts

Public ContactWei Bo

The Third Affiliated Hospital of Sun Yat-sen University

weibo3@mail.sysu.edu.cn+86 13527794069

Outcome results

None listed

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