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Cadonilimab in Locally Advanced MSI-H/dMMR Colorectal Cancer

Primary Purpose

dMMR Colorectal Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cadonilimab
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for dMMR Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

dMMR/MSI-H colon cancer

dMMR/MSI-H rectal cancer

Arm Description

Outcomes

Primary Outcome Measures

complete response rate
For colon cancer arm, complete response rate include the rate of pathological complete response and clinical complete response; for rectal cancer arm, complete response rate means the rate of clinical complete response

Secondary Outcome Measures

OS
Overall survival
DFS
Disease free survival
pCR rate
The rate of pathologic complete response for patients receiving surgery

Full Information

First Posted
April 1, 2023
Last Updated
April 13, 2023
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05815290
Brief Title
Cadonilimab in Locally Advanced MSI-H/dMMR Colorectal Cancer
Official Title
A Phase II Trial of Cadonilimab in Locally Advanced Stage II/III MSI-H/dMMR Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
March 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a two-arm phase II clinical study to evaluate the efficacy and safety of Cadonilimab (a PD-1/CTLA-4 bispecific antibody) in MSI-H/dMMR locally advanced colorectal cancer as the regimen of neoadjuvant treatment. Eligible patients will receive Cadonilimab monotherapy for eight cycles before surgery and part of patients may exempt from surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
dMMR Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dMMR/MSI-H colon cancer
Arm Type
Experimental
Arm Title
dMMR/MSI-H rectal cancer
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cadonilimab
Intervention Description
Cadonilimab 10mg/kg iv on day 1 for every 21 days with a total of 8 cycles
Primary Outcome Measure Information:
Title
complete response rate
Description
For colon cancer arm, complete response rate include the rate of pathological complete response and clinical complete response; for rectal cancer arm, complete response rate means the rate of clinical complete response
Time Frame
3 years
Secondary Outcome Measure Information:
Title
OS
Description
Overall survival
Time Frame
From date of initiation of treatment to date of death due to any cause, assessed up to 3 years
Title
DFS
Description
Disease free survival
Time Frame
From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 3 years
Title
pCR rate
Description
The rate of pathologic complete response for patients receiving surgery
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aiping Zhou, M.D.
Phone
86-10-87788800
Email
zhouap1825@126.com
Facility Information:
Facility Name
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aiping Zhou, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cadonilimab in Locally Advanced MSI-H/dMMR Colorectal Cancer

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