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The predictive role of radiomics in colorectal cancer patients with liver metastases receiving first-line treatment: a prospective, multicenter, phase II study

The predictive role of radiomics in colorectal cancer patients with liver metastases receiving first-line treatment: a prospective, multicenter, phase II study - Role of radiomics in the first-line treatment of colorectal cancer patients with liver metastases

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064768
Enrollment
Unknown
Registered
2022-10-17
Start date
2022-10-17
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

colorectal cancer

Interventions

Test group:standard treatment
Internal Validation group:standard treatment
External validation group:standard treatment

Sponsors

Fudan University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients must meet all of the following inclusion criteria to be eligible for entry into this study: 1. Age = 18 years old, gender is not limited; 2. Histopathologically diagnosed adenocarcinoma of the colon and rectum, and the primary tumor is clearly visible on the baseline CT scan; 3. Liver metastasis is confirmed by imaging examination, and there is at least one metastatic lesion on the liver whose longest transverse diameter is =1cm; 4. Patients with an ECOG score of 0-2 and an expected survival period of =3 months, who can cooperate to observe adverse reactions and curative effects; 5. Patients can tolerate enhanced CT examination; 6. No previous palliative chemotherapy 7. Has good organ function: (1) Neutrophils=1.5*109/L; Platelets=100*109/L; Hemoglobin=9g/dl; Serum Albumin=3g/dl; (2) Bilirubin=1.5 times the upper limit of normal; ALT and AST=2 times the upper limit of normal; (3) Serum creatinine = 1.5 times the upper limit of normal, and creatinine clearance rate = 60ml/min; 8. No serious concomitant diseases that make the survival period less than 5 years; 9. The pregnancy test for women of childbearing age must be negative, and the patient must take effective contraceptive measures during the study period and within 6 months after the end of the study; 10. A signed and dated informed consent form indicating that the patient has been informed of all relevant aspects of the study; 11. Patients who are willing and able to comply with visiting arrangements, treatment plans, laboratory tests and other research procedures;

Exclusion criteria

Exclusion criteria: 1. Pathological diagnosis of other intestinal tumors, such as gastrointestinal stromal tumor; 2. Disgnosed with or concurrent with other malignant tumors, excluding fully treated non-melanoma skin cancer, cervical carcinoma in situ and papillary thyroid carcinoma; 3. Have a history of immunodeficiency, including HIV positive test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; 4. History of interstitial lung disease (excluding radiation pneumonitis without hormone therapy), history of non-infectious pneumonia; 5. Severe cardiopulmonary and renal dysfunction; 6. A history of psychotropic substance abuse, alcoholism or drug use; 7. Other factors that may affect subject safety or trial compliance as judged by the investigator. such as serious medical conditions (including psychiatric disorders) requiring concomitant treatment, serious laboratory abnormalities, or other family or social factors; 8. Other situations in which the investigator believes that the patient is not suitable to participate in this trial;

Design outcomes

Primary

MeasureTime frame
objective remission rate predicted by radiomics model;

Secondary

MeasureTime frame
progress free survival predicted by radiomics model;overall survival predicted by radiomics model;progress free survival predicted by combinational model;overall survival predicted by combinational model;

Countries

China

Contacts

Public ContactZhiyu Chen

Fudan University Cancer Hospital

chanhj75@aliyun.com18721841159

Outcome results

None listed

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