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Capecitabine metronomic chemotherapy for maintenance treatment of metastatic colorectal cancer after reaching NED (no evidence of disease): a prospective, single center, randomized, controlled clinical study

Capecitabine metronomic chemotherapy for maintenance treatment of metastatic colorectal cancer after reaching NED (no evidence of disease): a prospective, single center, randomized, controlled clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047149
Enrollment
Unknown
Registered
2021-06-08
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-01-24

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:Capecitabine 500mg po bid

Sponsors

Zhongshan Affiliated Hospital, Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, aged from 18 to 70 years; 2. Pathologically diagnosed as colorectal adenocarcinoma; 3. At the time of initial diagnosis, enhanced CT or MRI showed that the clinical stage of colon cancer was stage IV with liver and/or lung metastasis, and R0 resection or radiofrequency ablation was performed on the primary tumor and metastatic lesions, the perioperative chemotherapy was completed, and the CT or MRI examination reached NED(No evidence of disease) within 4 weeks before enrollment; 4. ECOG PS 1-2; 5. There were no other underlying diseases affecting organ function; 6. Understand, be willing to give consent, and sign the written informed consent form prior to undergoing any study-specific procedure.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with more than one malignancy; 2. Pregnant or lactating women; 3. Patients with mental illness; 4. Combined with coronary heart disease, myocardial infarction, renal failure, pulmonary embolism and other diseases that may affect the survival of patients; 5. Patients with poor compliance can not cooperate with the treatment; 6. There is a known deficiency of dihydropyrimidine dehydrogenase (DPD), or Capecitabine intolerance.

Design outcomes

Primary

MeasureTime frame
progression-free survival, PFS;

Secondary

MeasureTime frame
overall survival, OS;

Countries

China

Contacts

Public ContactFang Cantu

Zhongshan Affiliated Hospital,Guangzhou University of Chinese Medicine

3568076269@qq.com+86 13902828479

Outcome results

None listed

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