Cadonilimab in Locally Advanced MSI-H/dMMR Colorectal Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Enrolling

Phase 2

Conditions

dMMR Colorectal Cancer

Treatments

Drug: Cadonilimab

Study type

Interventional

Funder types

Other

Identifiers

NCT05815290

NCC3626

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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