Status:
UNKNOWN
Evaluation of the Efficacy and Safety of Bevacizumab Combined With PD-1 Monoclonal Antibody in Preoperative Neoadjuvant Therapy for MSS Colorectal Cancer With Liver Metastases
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Brief Summary
Evaluation of the Efficacy and Safety of Bevacizumab Combined With PD-1 Monoclonal Antibody in Preoperative Neoadjuvant Therapy for MSS Colorectal Cancer With Liver Metastases - a Single-center, Singl...
Detailed Description
In the 2023 Global Cancer Statistics, colorectal cancer remains the third leading cause of cancer-related death in the world. According to the latest China Cancer report, colorectal cancer is the four...
Eligibility Criteria
Inclusion
- Men and women aged 18-75 years old;
- Histologically or radiographically proven colon or rectal adenocarcinoma with liver metastases；
- ECOG performance status score of 0 to 2；
- Clinical staged any T with liver metastases (M+);
- MSS status;
- Adequate haematological, hepatic, and renal function: neutrophil count ≥1.5×109 /L; platelet count ≥75×109 /L; serum total bilirubin ≤1.5×upper normal limits (UNL); aspartate aminotransferase ≤2.5×UNL; alanine aminotransferase ≤2.5×UNL; serum creatinine ≤1.5 x UNL.
Exclusion
- MSI status;
- Colorectal cancer without liver metastases;
- Relapsed colorectal cancer;
- Complicated with active bleeding, perforation, or requiring emergency surgery;
- Previous systemic anticancer therapy for colorectal cancer disease;
- Any active or history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications;
- Patients with other active concurrent non-colorectal cancer;
- Patients with interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as: diabetes, hypertension, pulmonary fibrosis and acute pneumonia);
- Patients with any Grade 2 or above toxicity as classified by the common terminology criteria for adverse events (CTCAE) (version 5.0) (except for anemia, alopecia and skin pigmentation) which is induced by previous treatment and has not subside;
- Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti- cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody Women in pregnancy or lactation;
- Known positive history or positive test for Human Immunodeficiency Virus or Acquired Immunodeficiency Syndrome (AIDS);
- History of known or suspected allergies to any related drugs used in the trial; Women who are pregnant or nursing.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06124729
Start Date
December 1 2023
End Date
December 1 2024
Last Update
November 9 2023
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