Combining Cadonilimab with XELOX for advanced rectal cancer treatment
XELOX Combined With Cadonilimab Versus XELOX as Neoadjuvant Treatment for MRF-negative Locally Advanced, pMMR Rectal Cancer: a Randomised, Phase 2 Trial
This study is testing if combining a new antibody treatment with standard chemotherapy can help people with advanced rectal cancer have better outcomes after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 75 Years |
| 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 | NCT05815303 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of Cadonilimab, a bispecific antibody targeting PD-1 and CTLA-4, in combination with the XELOX chemotherapy regimen for patients with locally advanced, mismatch repair proficient rectal cancer. Participants will be randomly assigned to receive either the combination treatment or XELOX alone for four cycles before and after surgery. The primary goal is to assess the rate of pathological complete response in the two groups. This study aims to improve treatment outcomes for patients with this specific type of cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with locally advanced rectal adenocarcinoma that is mismatch repair proficient and has not been previously treated.
Not a fit: Patients with distant metastasis, other types of cancer, or those who have received prior chemotherapy or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to higher rates of complete tumor response and improved surgical outcomes for patients with advanced rectal cancer.
How similar studies have performed: While the combination of immunotherapy and chemotherapy is a growing area of interest, this specific approach is novel and has not been extensively tested in similar trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or pathologically confirmed rectal adenocarcinoma located within 5 to 15cm from the anus with a stage of T3-4a or N+ according to the CT or endoscope * Mesorectal fascia uninvolved * Sign the informed consent form * 18 years and older * Mismatch repair proficient determined by immunohistochemistry * No prior treatment * Performance status: ECOG 0-1 * Good organ function: Blood routine: hemoglobin ≥90g/L, neutrophil ≥1.5×10\^9/L, platelet ≥100×10\^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 * Unable to swallow or under other circumstance which would drug absorption * 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.