MSS, Rectal Cancer
Conditions
Brief summary
This is a two-arm, open label, randomized phase II clinical study. The aim is to evaluate the safety and efficacy of Cadonilimab (a PD-1/CTLA-4 bispecific antibody) combined with XELOX regimen in pMMR locally advanced rectal cancer during the perioperative period. Eligible patients will receive either Cadonilimab plus XELOX or XELOX alone for 4 cycles before and 4 cycles after surgery. The primary endpoint is the pathological complete response rate.
Interventions
DRUGCadonilimab
10mg/kg iv on day 1, every 21 day
DRUGOxaliplatin
130mg/m2 iv on day 1, every 21 day
DRUGCapecitabine
1000mg/m2 po bid on day 1 to 14, every 21 day
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR | 3 years | the rate of pathological complete response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MPR | 3 years | the rate of major pathological response according to Becker-TRG |
| DFS | From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 3 years | disease free survival |
| OS | From date of initiation of treatment to date of death, assessed up to 3 years | overall survival |
Countries
China
Contacts
Primary ContactAiping Zhou, M.D.
Outcome results
None listed