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

NCT05815303 | Recruiting Phase 2

• 1 other identifier: NCC3627
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer; MSS

Outcome Measures

Primary Outcomes (1)

• pCR

  the rate of pathological complete response

  3 years

Secondary Outcomes (3)

• MPR

  3 years

• 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

• OS

  From date of initiation of treatment to date of death, assessed up to 3 years

Study Arms (2)

Cadonilimab + XELOX

EXPERIMENTAL

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

Drug: Cadonilimab; Drug: Oxaliplatin; Drug: Capecitabine

XELOX

SHAM COMPARATOR

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

Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Cadonilimab DRUG

10mg/kg iv on day 1, every 21 day

Cadonilimab + XELOX

Oxaliplatin DRUG

130mg/m2 iv on day 1, every 21 day

Cadonilimab + XELOX; XELOX

Capecitabine DRUG

1000mg/m2 po bid on day 1 to 14, every 21 day

Cadonilimab + XELOX; XELOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

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

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Aiping Zhou, M.D.

CONTACT

86-10-87788800; zhouap1825@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director of Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital

Study Record Dates

• First Submitted: April 1, 2023
• First Posted: April 18, 2023
• Study Start: March 29, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (1)