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Trial Title:
Cadonilimab in Locally Advanced MSI-H/dMMR Colorectal Cancer
NCT ID:
NCT05815290
Condition:
dMMR Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab
Description:
Cadonilimab 10mg/kg iv on day 1 for every 21 days with a total of 8 cycles
Arm group label:
dMMR/MSI-H colon cancer
Arm group label:
dMMR/MSI-H rectal cancer
Summary:
This is a two-arm phase II clinical study to evaluate the efficacy and safety of
Cadonilimab (a PD-1/CTLA-4 bispecific antibody) in MSI-H/dMMR locally advanced colorectal
cancer as the regimen of neoadjuvant treatment. Eligible patients will receive
Cadonilimab monotherapy for eight cycles before surgery and part of patients may exempt
from surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Arm 1: Histologically or pathologically confirmed colon adenocarcinoma with a stage
of T3-4 or N+ according to the CT or endoscope; Arm 2: Histologically or
pathologically confirmed rectal adenocarcinoma located within 12cm from the anus
with a stage of T2-4 or N+ according to the CT or endoscope
- Sign the informed consent form
- 18 years and older
- Mismatch repair deficient determined by immunohistochemistry or microsatellite
instable by PCR
- No prior treatment
- Performance status: ECOG 0-1
- Good organ function:
Blood routine: hemoglobin ≥90g/L, neutrophil ≥1.5×10^9/L, platelet ≥80×10^9/L; Renal
function: creatinine≤1.5×upper limit of normal (UNL) or creatinine clearance ≥50ml/min;
Liver function: total bilirubin (TBIL)≤1.5×upper limit of normal (UNL); ALT≤2.5×UNL,
AST≤2.5×UNL; Ejection fraction at least 50% (or lower limit of normal) by echocardiogram
Exclusion Criteria:
- Other pathological category, such as squamous cancer
- Distant metastasis or peritoneum implantation
- Have received chemotherapy or radiotherapy in the past
- Known to have allergic reactions to any ingredients or excipients of experimental
drugs
- Other active malignant tumors, excluding those who have been disease free for more
than 5 years or in situ cancer considered to have been cured by adequate treatment
- Have received colorectal cancer surgery
- Diabetes was not controlled, defined as HbA1c > 7.5% after anti-diabetic drugs or
hypertension was not controlled, defined as systolic / diastolic blood pressure >
140 / 90 mmHg after antihypertensive drug
- Myocardial infarction, severe/unstable angina, New York Heart Association (NYHA)
class III or IV congestive heart failure in the past 12 months
- Known to be infected with human immunodeficiency virus (HIV), have acquired
immunodeficiency syndrome (AIDS) related diseases, have active hepatitis B or
hepatitis C
- Pregnant or nursing
- May increase the risk associated with participation in the study or administration
of the study drug or mental illness that may interfere with the interpretation of
research results
- There are other serious diseases that the researchers believe patients cannot be
included in the study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Aiping Zhou, MD
Start date:
March 29, 2023
Completion date:
March 30, 2026
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05815290
