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Clinical value evaluation of whole genome sequencing combined with dynamic circulating tumor cells in the conversion therapy of initial unresectable colorectal cancer liver metastasis

Clinical value evaluation of dynamic circulating tumor cells in the conversion therapy of initial unresectable colorectal cancer liver metastasis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400086753
Enrollment
Unknown
Registered
2024-07-10
Start date
2024-07-20
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

circulating tumor cells

Interventions

Simultaneous colorectal cancer liver metastasis:Haemospasia
Simultaneous and heterochronous colorectal cancer liver metastasis:Tissue biopsy

Sponsors

The 10th People's Hospital affiliated to Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Age 18-70 years old (including the cut-off value), male or female; 2) Expected survival =3 months; 3) KPS score = 60 points, and there are no contraindications for various biochemical indicators; 4) ECOS PS 0 points; 5) Liver function Child-Pugh class A; 6) The primary disease is confirmed by pathology to be colorectal cancer, and the liver lesion is confirmed to be liver metastatic tumor by imaging examination or biopsy pathology; 7) Dynamic contrast-enhanced MRI of the liver was performed before surgery, and CRLM was assessed as unresectable at initial diagnosis (according to the eighth edition of TNM staging, the T stage of the tumor is T1-T3; there is no distant organ metastasis); 8) Imaging shows that the metastasis is limited to the liver, and there is no tumor thrombus or extrahepatic metastasis in blood vessels, bile ducts and other parts; a single tumor, the diameter of the tumor is > 5 cm; or multiple tumors, the number of tumors is > 5, and the maximum diameter is > 4 cm; 9) Pregnant women who are not pregnant or breastfeeding should take contraceptive measures within 6 months after the end of treatment; 10) Laboratory tests within 1 week before treatment (including conversion therapy and surgery) must meet the following standards: A) Routine blood tests: a) Hemoglobin (Hb) =90 g/L; b) Neutrophil count (ANC) =1.5×109/L; c) Platelet count (PLT) =75×109/L; B) Biochemical examination: a) Albumin (ALB) =35 g/L; b) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 × ULN; c) Total bilirubin (TBIL) =1.5×ULN; d) Creatinine (Cr) = 1.5 × ULN or creatinine clearance (Ccr) = 60 mL/min; C) Electrolytes are basically normal or normal after treatment; D) Urinary protein <2+ or 24-hour urine protein quantitative test =1.0 g/L (for patients with urine protein =2+, a 24-hour urine protein quantitative test must be =1.0 g/L before they can be selected); E) Coagulation function: a) International standard ratio (INR) or prothrombin time (PT) = 1.2 × ULN; b) Activated partial coagulation time (APTT) =1.5×ULN; F) T3 and T4 levels =2×ULN?

Exclusion criteria

Exclusion criteria: 1) Pathologically diagnosed as hepatocellular carcinoma, mixed hepatocellular-intrahepatic cholangiocarcinoma or other non-cholangiocytic malignant tumors; 2) Expected survival period 10 mg) or other types of immunosuppressive therapy, topical or oral corticosteroids can be included 10) Acute infectious diseases requiring treatment; 11) HIV positive; 12) Previous history of psychotropic drugs, alcohol or drug abuse; 13) Have obvious bleeding symptoms or clear bleeding tendency in the past 3 months; 14) Those who are allergic or suspected of being allergic to the trial drug; 15) Hypertensive patients have poor blood pressure control after antihypertensive drug treatment (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg); 16) Metastasis to other sites other than liver metastasis or combined with tumors other than colon cancer; 17) Those who have uncontrollable hepatic encephalopathy, ascites, Gilbert syndrome, sclerosing cholangitis, etc.; who are combined with other organ dysfunction and are not expected to tolerate surgery or liver resection; 18) Anyone else who the researcher thinks cannot be included in the group

Design outcomes

Primary

MeasureTime frame
object response rate, ORR;

Secondary

MeasureTime frame
overall Survival, OS;Adverse events of chemotherapy;

Countries

China

Contacts

Public ContactLi Jun

The 10th People's Hospital affiliated to Tongji University

lijundfgd1@163.com+86 189 3056 0396

Outcome results

None listed

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