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

Primary Purpose

Rectal Cancer, MSS

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cadonilimab
Oxaliplatin
Capecitabine
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 Rectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sham Comparator

Arm Label

Cadonilimab + XELOX

XELOX

Arm Description

Oxaliplatin 130 mg/m2 iv and Cadonilimab 10mg/kg iv on day 1; Capecitabine 1000mg/m2 po bid on day 1 to 14; every 21 day as a cycle, 4 cycles before surgery and 4 cycles after surgery

Oxaliplatin 130 mg/m2 iv on day 1; Capecitabine 1000mg/m2 po bid on day 1 to 14; every 21 day as a cycle, 4 cycles before surgery and 4 cycles after surgery

Outcomes

Primary Outcome Measures

pCR
the rate of pathological complete response

Secondary Outcome Measures

MPR
the rate of major pathological response according to Becker-TRG
DFS
disease free survival
OS
overall survival

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
NCT05815303
Brief Title
XELOX Combined With Cadonilimab Versus XELOX as Neoadjuvant Treatment for Locally Advanced, pMMR Rectal Cancer
Official Title
XELOX Combined With Cadonilimab Versus XELOX as Neoadjuvant Treatment for MRF-negative Locally Advanced, pMMR Rectal Cancer: a Randomised, Phase 2 Trial
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
March 2025 (Anticipated)
Study Completion Date
March 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, MSS

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cadonilimab + XELOX
Arm Type
Experimental
Arm Description
Oxaliplatin 130 mg/m2 iv and Cadonilimab 10mg/kg iv on day 1; Capecitabine 1000mg/m2 po bid on day 1 to 14; every 21 day as a cycle, 4 cycles before surgery and 4 cycles after surgery
Arm Title
XELOX
Arm Type
Sham Comparator
Arm Description
Oxaliplatin 130 mg/m2 iv on day 1; Capecitabine 1000mg/m2 po bid on day 1 to 14; every 21 day as a cycle, 4 cycles before surgery and 4 cycles after surgery
Intervention Type
Drug
Intervention Name(s)
Cadonilimab
Intervention Description
10mg/kg iv on day 1, every 21 day
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130mg/m2 iv on day 1, every 21 day
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
1000mg/m2 po bid on day 1 to 14, every 21 day
Primary Outcome Measure Information:
Title
pCR
Description
the rate of pathological complete response
Time Frame
3 years
Secondary Outcome Measure Information:
Title
MPR
Description
the rate of major pathological response according to Becker-TRG
Time Frame
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
OS
Description
overall survival
Time Frame
From date of initiation of treatment to date of death, assessed up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
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
Undecided

Learn more about this trial

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

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