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Single center, randomized, controlled clinical study of primary tumor resection combined with chemotherapy versus chemotherapy in the treatment of unresectable colorectal cancer with oligometastases

Single center, randomized, controlled clinical study of primary tumor resection combined with chemotherapy versus chemotherapy in the treatment of unresectable colorectal cancer with oligometastases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036502
Enrollment
Unknown
Registered
2020-08-23
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-14

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:Tumor resection combined with chemotherapy
control group:chemotherapy

Sponsors

Department of Oncology, Changhai Hospital of Shanghai, the Second Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
17 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1. Age: >= 18 years old, = 90g/L b. ANC >= 1.5 x 10^9/L c. PLT >= 80 x 10^9/L (2) Biochemical examination should meet the following standards: a. Bil 50ml / min (Cockcroft Gault male) Formula); 11. Women of childbearing age must have a pregnancy test (serum) within 7 days before enrollment, and the results are negative, and they are willing to use appropriate contraceptive methods during the trial and 8 weeks after the last administration of the trial drug; for men, it should be surgical sterilization, or agree to use appropriate contraceptive methods during the trial and 8 weeks after the last administration of the trial drug; 12. The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Previous or concurrent malignancies except basal cell carcinoma of skin and carcinoma in situ of cervix that have been cured; 2. Metastatic colorectal cancer can be resected; 3. The patients were MSI-H population 4. 2 bone or brain metastases or symptomatic single brain metastases; 5. Patients with hypertension who can not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 6. Patients with grade I or above coronary heart disease, arrhythmia (including QTc interval prolongation, > 450ms in males and 470ms in females), and cardiac insufficiency; 7. Patients with positive urine protein (urine protein test 2 + or above, or 24-hour urinary protein quantitative > 1.0g); 8. Patients with definite gastrointestinal bleeding tendency; 9. Abnormal coagulation function (INR > 1.5, APTT > 1.5 ULN) with bleeding tendency; 10. Patients with a history of psychotropic substance abuse and unable to quit or with mental disorders; 11. Patients who have participated in clinical trials of other drugs within 4 weeks; 12. According to the judgment of the researcher, there are other patients with concomitant diseases that seriously endanger the safety of patients or affect patients to complete the study. 13. Pregnant or lactating women; 14. The researchers considered that it was not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
OS;

Countries

China

Contacts

Public ContactWei Wang

Department of Oncology, Changhai Hospital of Shanghai, the Second Military Medical University

easylifeww@126.com+86 13801663523

Outcome results

None listed

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