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MRD status analysis to optimize adjuvant treatment in patients with stage II or III colorectal cancer: prospective, double-arm, multi-center clinical study

MRD status analysis to optimize adjuvant treatment in patients with stage II or III colorectal cancer: prospective, double-arm, multi-center clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049342
Enrollment
Unknown
Registered
2021-07-31
Start date
2021-07-27
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

colorectal cancer

Interventions

MRD negative patients:Phase II low risk: R=1:1
Observation: capecitabine 6m
MRD negative patients:Stage II high-risk/stage III: R=1:1
capecitabine 6m: CapeOX 3m

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 75 years; 2.Liver function Child A: total bilirubin=28 g/L, AST, ALT, ALP=1.5x10^9/L, Hb>=8.5g/L, PLT>=75x10^9/L; 4.Coagulation function: INR<=2.3; 5.ECOG score <=2 points; 6.The pathological result is (colon or rectum) adenocarcinoma; 7.Understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Women who are pregnant or breastfeeding; 2.Patients with other malignant tumors; 3.Patients with mental illness; 4.Patients who have participated in other clinical trials in the past 3 months; 5.Patients who have received chemotherapy in the past 6 months; 6.History of allergy to chemotherapy drugs and their components; 7.History of severe arrhythmia and heart failure; 8.History of severe ventilation dysfunction and severe pulmonary infection; 9.Acute and chronic renal failure, creatinine clearance rate >40 mL/min.

Design outcomes

Primary

MeasureTime frame
3-year disease-free survival;

Secondary

MeasureTime frame
Overall survival;

Countries

China

Contacts

Public ContactGu Lei

Shanghai Tenth People's Hospital

toughstone1984@163.com+86 19921602760

Outcome results

None listed

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