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Trial Title:
XELOX Combined With Cadonilimab Versus XELOX as Neoadjuvant Treatment for Locally Advanced, pMMR Rectal Cancer
NCT ID:
NCT05815303
Condition:
Rectal Cancer
MSS
Conditions: Official terms:
Rectal Neoplasms
Capecitabine
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab
Description:
10mg/kg iv on day 1, every 21 day
Arm group label:
Cadonilimab + XELOX
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
130mg/m2 iv on day 1, every 21 day
Arm group label:
Cadonilimab + XELOX
Arm group label:
XELOX
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
1000mg/m2 po bid on day 1 to 14, every 21 day
Arm group label:
Cadonilimab + XELOX
Arm group label:
XELOX
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
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 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/NCT05815303
