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Establishment and validation of therapeutic effect prediction model of first line treatment of bevacizumab combined with mFOLFOX6 in Ras mutant colorectal cancer patients with liver metastasis

The Prediction Model of Avastin Plus Chemotherapy in Unresectable Ras Mutant CRLM Patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000036551
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-09-01
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

Gold Standard:Clinical outcome
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prediction&#32
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bevacizumab&#32
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mFOLFOX6&#32
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Ras&#32
cancer&#32
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Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Adult patients, aged 18-75 years. 2) Colonoscopic biopsy confirmed colorectal adenocarcinoma. 3) Ras mutation. 4) Preoperative imaging diagnosis of colorectal cancer liver metastasis. 5) Unresectable liver metastases by multidisciplinary assessment. 6) The hemopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of operation and anesthesia. 7) Physical strength score 0-1. 8) The expected survival was more than 3 months. 9) Sign informed consent.

Exclusion criteria

Exclusion criteria: 1) had a history of malignant colorectal tumor. 2) Recent diagnosis of other malignant tumors. 3) Patients who have participated in or are participating in other clinical trials within 4 weeks before enrollment. 4) Liver metastases can be initially resectable. 5) ASA grade >= IV and / or ECoG physical status score >= 2. 6) Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or severe basic diseases can not tolerate surgery. 7) Have a history of serious mental illness. 8) Pregnant or lactating women. 9) Patients with other clinical and laboratory conditions considered by some researchers should not participate in the trial.

Design outcomes

Primary

MeasureTime frame
Objective response rate;SEN, SPE, ACC, AUC of ROC, PPV, NPV;

Secondary

MeasureTime frame
progression free survival;overall survival;

Countries

China

Contacts

Public ContactWentao Tang

Zhongshan Hospital, Fudan University

tangwt1988@163.com+86 18317121626

Outcome results

None listed

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