XELOX Combined With Cadonilimab Versus XELOX as Neoadjuvant Treatment for Locally Advanced, pMMR Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

XELOX Combined With Cadonilimab Versus XELOX as Neoadjuvant Treatment for MRF-negative Locally Advanced, pMMR Rectal Cancer: a Randomised, Phase 2 Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05815303
• Other study ID #: NCC3627
• Status: Recruiting
• Phase: Phase 2
• Start date: March 29, 2023
• Est. completion date: March 2026

Study information

• Verified date: April 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Aiping Zhou, M.D.
• Phone: 86-10-87788800
• Email: zhouap1825[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• MSS
• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Cadonilimab
10mg/kg iv on day 1, every 21 day
• Oxaliplatin
130mg/m2 iv on day 1, every 21 day
• Capecitabine
1000mg/m2 po bid on day 1 to 14, every 21 day

Locations

Country	Name	City	State
China	National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR	the rate of pathological complete response	3 years
Secondary	MPR	the rate of major pathological response according to Becker-TRG	3 years
Secondary	DFS	disease free survival	From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 3 years
Secondary	OS	overall survival	From date of initiation of treatment to date of death, assessed up to 3 years