Last updated: December 26, 2023
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting
Phase
2
Condition
Colorectal Cancer
Colon Cancer
Colon Cancer; Rectal Cancer
Treatment
mFOLFOXIRI
mFOLFOX6
mFOLFOXIRI + Cadonilimab
Clinical Study ID
NCT05571644
GIHSYSU-15
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged 18-70;
- Colorectal adenocarcinoma with definite histological evidence;
- ECOG Performance status score is 0-1
- Colon cancer was evaluated as T3>5mm or T4 by contrast-enhanced CT examination of thechest, abdomen and pelvis, and distant displacement was excluded; Rectal cancer wasgraded as T3-4 and/or N+ by pelvic contrast-enhanced MRI examination, and the lowermargin of the tumor was less than 12cm away from the anal margin. Distant metastasiswas excluded by chest, abdomen and pelvis CT.
- The primary rectal tumor was assessed as complete resections by a multidisciplinarycollaboration group on colorectal cancer, including at least 2 gastrointestinalsurgeons and 1 radiologist;
- No previous systemic antitumor therapy for colorectal cancer, including cytotoxicdrugs, immunotherapy, molecular targeted therapy, etc.;
- Adequate organ function based on the following laboratory test values obtained within 7 days prior to treatment: Hemoglobin ≥90g/L, neutrophil count ≥1.5×109/L, platelet count ≥75×109/L, serum totalbilirubin ≤1.5× upper limit of normal value (UNL), aspartate transferase ≤2×UNL,alanine transferase ≤3×UNL, serum creatinine ≤1.5×UNL;
- Willing and able to comply with research protocols and visit plans.
Exclusion
Exclusion Criteria:
- The patient was complicated with obstruction, active bleeding, or perforation andrequired emergency surgery or stent placement;
- Active, known or suspected autoimmune diseases (except type I diabetes, residualhypothyroidism requiring only hormone replacement due to autoimmune conditions, orautoimmune diseases that are not expected to recur in the absence of externaltriggers);
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiencysyndrome (AIDS), untreated active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500IU/ml; Hepatitis C, defined as HCV-RNA above the detection limit of the assay) orco-infection with hepatitis B and C;
- Known allergy to the treatment drug or allergy or intolerance to its ingredients;
- Major surgery or severe trauma, such as laparotomy, thoracotomy, laparoscopic organresection, etc. within the previous 4 weeks (the surgical incision should becompletely healed before enrollment);
- Existing or coexisting other active malignancies (except those that have been treatedwith curative therapy and remain disease-free for more than 5 years or carcinoma insitu that can be cured by adequate treatment);
- Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody andanti-cytotoxic T-lymphocyte-associated protein 4 (Cytotoxic T-lymphocyte-associatedprotein 4) antibody. Ctla-4) antibodies or other drugs/antibodies that act on T-cellcostimulatory or checkpoint pathways;
- Had active coronary artery disease, severe/unstable angina pectoris or newly diagnosedangina pectoris or myocardial infarction within 6 months prior to study enrollment;Thrombotic or embolic events, such as cerebrovascular accident (including transientischemic attack), pulmonary embolism, deep vein thrombosis, occurred within theprevious 6 months;
- The New York Heart Association (NYHA) class II or higher congestive Heart failure (seeAppendix 3);
- Presence of active inflammatory bowel disease or other colorectal disease leading tochronic diarrhea;
- The presence of any toxicity (Common Terminology Criteria for Adverse Events, CTCAE) (version 5.0) grade 1 or above (except anemia, alopecia, and skin pigmentation) causedby previous treatment that has not subsided;
- Previous or current history of pulmonary fibrosis, interstitial pneumonia,pneumoconiosis, drug-related pneumonia, severe impairment of pulmonary function andother lung diseases;
- Active tuberculosis (TB), receiving anti-TB therapy or receiving anti-TB therapywithin 1 year before the first dose;
- Persons with known syphilis infection requiring treatment;
- Had used immunosuppressive drugs within 4 weeks before the first dose, Does notinclude the nasal spray, inhalation, or other ways of topical corticosteroids orphysiological doses of systemic corticosteroids (i.e., no more than 10 mg/dayprednisone or other equivalent dose glucocorticoids), allows for prevention ofallergic reactions, or treatment of diseases such as asthma, chronic obstructivepulmonary disease of breathing difficulties for the temporary use of glucocorticoid;
- Receive live attenuated vaccine within 4 weeks before the first dose or during thestudy period;
- Pregnant or lactating women; Women of reproductive age (< 2 years after lastmenstruation) who do not use or refuse to use effective non-hormonal contraception ormen at risk of having children.
Study Design
Total Participants: 143
Treatment Group(s): 3
Primary Treatment: mFOLFOXIRI
Phase: 2
Study Start date:
July 10, 2023
Estimated Completion Date:
December 15, 2025
Study Description
Connect with a study center
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510655
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.