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A randomized, controlled, multicenter clinical trial of Fruquintinib combined with TAS-102 with Fruquintinib in the treatment of advanced metastatic colorectal cancer with standard treatment failure

A randomized, controlled, multicenter clinical trial of Fruquintinib combined with TAS-102 with Fruquintinib in the treatment of advanced metastatic colorectal cancer with standard treatment failure

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047021
Enrollment
Unknown
Registered
2021-06-07
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-01-18

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

Conditions

colorectal cancer

Interventions

Experimental group:Give fruquintinib combined with TAS-102

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 75 years, male or female; 2.After colonoscopy and histopathological biopsy, the diagnosis was confirmed as primary colon cancer or primary rectal cancer; 3.The tumor was metastatic and advanced after second-line treatment (including fluorouracil, oxaliplatin and irinotecan); 4.More than 1 month after the last chemotherapy; 5.Karnofsky score >= 80, or ECoG physical condition score >= 1, and estimated survival time >= 3 months; 6.Those who did not participate in other clinical studies; 7.Hypertension was well controlled; 8.Adequate blood function: absolute neutrophil count (ANC) >= 2 x 10^9/L and platelet count >= 100 x 10^9/L and hemoglobin >= 9 g/dl; 9.Sufficient liver function: total bilirubin = 60 ml / min; 11.ECG was normal and there was no unhealed wound in the body; 12.All tumors had at least one measurable lesion; 13.They signed informed consent and volunteered to participate in this study.

Exclusion criteria

Exclusion criteria: 1.Patients with bone marrow suppression, prone to infection and bleeding risk; 2.They were complicated with severe cardiovascular and cerebrovascular diseases; 3.Patients with warfarin, heparin and other drugs, or with hematopoiesis abnormality; 4.They were not conscious and could not express their subjective symptoms and mental illness.

Design outcomes

Secondary

MeasureTime frame
Total survival time;Safety of the experimental group;Quality of life;

Primary

MeasureTime frame
Progression-free survival;

Countries

China

Contacts

Public ContactYin Xude

Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China

yinxude@163.com+86 1890819031

Outcome results

None listed

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