Cadonilimab in Locally Advanced MSI-H/dMMR Colorectal Cancer

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05815290
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
dMMR Colorectal Cancer	Drug: Cadonilimab	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Cadonilimab in Locally Advanced Stage II/III MSI-H/dMMR Colorectal Cancer
• Actual Study Start Date: Mar 29, 2023
• Anticipated Primary Completion Date: Sep 30, 2024
• Anticipated Study Completion Date: Mar 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dMMR/MSI-H colon cancer	Drug: Cadonilimab; Cadonilimab 10mg/kg iv on day 1 for every 21 days with a total of 8 cycles
Experimental: dMMR/MSI-H rectal cancer	Drug: Cadonilimab; Cadonilimab 10mg/kg iv on day 1 for every 21 days with a total of 8 cycles

Outcome Measures

Primary Outcome Measures

1. complete response rate [3 years]

   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

1. OS [From date of initiation of treatment to date of death due to any cause, assessed up to 3 years]

   Overall survival

2. 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

3. pCR rate [2 year]

   The rate of pathologic complete response for patients receiving surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AIPING ZHOU, Vice director of Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• ClinicalTrials.gov Identifier: NCT05815290
• Other Study ID Numbers: NCC3626
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 18, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Apr 18, 2023