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Trial Title:
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
NCT ID:
NCT06124729
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Antibodies
Antibodies, Monoclonal
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Bevacizumab Combined With PD-1 Monoclonal Antibody
Description:
Bevacizumab Combined With PD-1 Monoclonal Antibody in Preoperative Neoadjuvant Therapy
for MSS colorectal cancer with liver metastases
Arm group label:
Bevacizumab Combined With PD-1 Monoclonal Antibody in Preoperative Neoadjuvant Therapy
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, Single-arm, Open-label Clinical Trail.
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 fourth leading cause of cancer-related death in China. More
specifically, the incidence and the mortality of colorectal cancer have been increasing
year over year. Among newly diagnosed colorectal cancer patients, 20% have distant
metastases. The 5-year survival rate for metastatic colorectal cancer (mCRC) is less than
20%. In the latest updated 2023 National Cancer Comprehensive Network (NCCN) Colon Cancer
Guidelines, mismatch repair genes/micro satellite state officially became a global
classification standard. Patients diagnosed with colorectal cancer must be classified
into MSS or MSI-H before treatment, that is, patients are divided into pMMR/MSS and
dMMR/MSI-H subtypes after initial examination or clinical management, and then the
treatment plan is determined. MSI-H accounts for 15% of all colorectal cancers and is
mostly present in patients with early stage tumors. For patients with metastatic
colorectal cancer, MSI-H colorectal cancer accounts for only 5% of all patients. Among
them, the treatment of immune checkpoint inhibitors in MSI-H patients has become a
first-line and neoadjuvant metastatic disease treatment recommendation.
Although clinical trials on the combination of targeted therapy and immunotherapy are
increasing, clinical researches and clinical trials of targeted therapy combined
immunotherapy, such as bevacizumab combined with PD-1, have not received enough attention
and recognition. Currently reports believed that anti-programmed death-1 (PD-1)
antibodies have been shown to produce significantly longer progression-free survival with
fewer adverse events compared to chemotherapy as a first-line treatment for dMMR
metastatic CRC (mCRC). In the simultaneous CRT sequential PD-1 (long range) and TNT
simultaneous combined PD-1 (long range) clinical trials, CRT combined with PD-1/PD-L1
showed better near-term efficacy gains (pCR) in patients with locally staged pMMR.
Although current researches on neoadjuvant therapy for MSS type bowel cancer is
increasingly abundant, especially PD-1 is becoming more and more popular in the treatment
of MSS type bowel cancer, the research in the field of neoadjuvant therapy for MSS
metastatic colorectal cancer is still not explored. Therefore, our PD-1 combined with
bevacizumab in the treatment of MSS type metastatic bowel cancer has greatly research
value.
Based on the above reasons, we designed this study to observe the efficacy and safety of
the target-free combination therapy regimen of PD-1 combined with bevacizumab for
patients with MSS metastatic colorectal cancer, and strive to provide a high-level
evidence-based basis for neoadjuvant therapy regimen for patients with MSS metastatic
colorectal cancer.
Criteria for eligibility:
Study pop:
Patients with MSS colorectal cancer who have been diagnosed with liver metastases and are
physically able to tolerate neoadjuvant chemotherapy.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Men and women aged 18-75 years old;
2. Histologically or radiographically proven colon or rectal adenocarcinoma with liver
metastases；
3. ECOG performance status score of 0 to 2；
4. Clinical staged any T with liver metastases (M+);
5. MSS status;
6. 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 Criteria:
1. MSI status;
2. Colorectal cancer without liver metastases;
3. Relapsed colorectal cancer;
4. Complicated with active bleeding, perforation, or requiring emergency surgery;
5. Previous systemic anticancer therapy for colorectal cancer disease;
6. Any active or history of autoimmune disease, or history of syndrome that required
systemic steroids or immunosuppressive medications;
7. Patients with other active concurrent non-colorectal cancer;
8. Patients with interstitial lung disease, non-infectious pneumonia or uncontrollable
systemic diseases (such as: diabetes, hypertension, pulmonary fibrosis and acute
pneumonia);
9. 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;
10. 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;
11. Known positive history or positive test for Human Immunodeficiency Virus or Acquired
Immunodeficiency Syndrome (AIDS);
12. History of known or suspected allergies to any related drugs used in the trial;
Women who are pregnant or nursing.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
December 2023
Completion date:
December 2024
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06124729
