Using Cadonilimab for advanced colorectal cancer treatment
A Phase II Trial of Cadonilimab in Locally Advanced Stage II/III MSI-H/dMMR Colorectal Cancer
This study is testing if a new treatment called Cadonilimab can help people with advanced colorectal cancer feel better before surgery and possibly avoid surgery altogether.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy, Cadonilimab |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05815290 on ClinicalTrials.gov |
What this trial studies
This phase II clinical study evaluates the efficacy and safety of Cadonilimab, a bispecific antibody targeting PD-1 and CTLA-4, in patients with locally advanced colorectal cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). Participants will receive Cadonilimab monotherapy for eight cycles as neoadjuvant treatment before surgery, with some patients potentially exempt from surgery based on their response. The study aims to determine how well this treatment works compared to standard approaches.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with locally advanced dMMR or MSI-H colorectal cancer who have not received prior treatment.
Not a fit: Patients with other types of cancer or those with distant metastasis will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced colorectal cancer, potentially improving outcomes and reducing the need for surgery.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Aiping Zhou, M.D.
- Email: zhouap1825@126.com
- Phone: 86-10-87788800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.