Triplezumab Combined With CAPEOX Regimen in Neoadjuvant Therapy for Locally Advanced Colon Cancer

  • STATUS
    Recruiting
  • days left to enroll
    9
  • participants needed
    30
  • sponsor
    The First Affiliated Hospital of Xiamen University
Updated on 24 January 2021

Summary

According to the 2019NCCN guidelines, immunocheckpoint inhibitors are recommended for first-line treatment of metastatic colon cancer patients with high microsatellite instability (msi-h) or mismatched gene deletion (dMMR) who are not suitable for intensive treatment, and for all patients with second-line or above msi-h /dMMR treatment.This study is a single-center, single-arm phase II study of the use of triplezumab (JS001) combined with CAPEOX regimen in the neoadjuvant therapy of msi-h /dMMR for locally advanced colon cancer. The subjects received neoadjuvant therapy with triplezumab (JS001) combined with CAPEOX regimen, with one treatment cycle every 3 weeks and two cycles of surgery followed by pathological evaluation.

Details
Condition Locally Advanced Colon Cancer
Treatment Toripalimab
Clinical Study IdentifierNCT04389151
SponsorThe First Affiliated Hospital of Xiamen University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Locally Advanced Colon Cancer?
Do you have any of these conditions: Do you have Locally Advanced Colon Cancer??
Sign written informed consent
Age 18 years
ECOG physical condition score 1
Pathological diagnosis of msi-h /dMMR colon cancer
The TNM stage of colon cancer was ct3/4nxm0 or ctxn1/2m0
Never received anti-tumor treatment including but not limited to radiotherapy, chemotherapy and surgery
The patient must have adequate organ function and meet the following laboratory test values during the screening period within 7 days before enrolling
Absolute neutrophil cell count (ANC) 1.5x109/L, platelet 100x109/L, hemoglobin 90g/L.(in (Patients with no blood transfusion or growth factor support should be given for 7 days prior to blood collection.)
Serum creatinine 1.5 upper normal range (ULN) or estimated creatinine clearance 50mL/min
Total bilirubin 1.5ULN;If there is Gilbert syndrome or if the indirect bilirubin concentration indicates an extrahepatic source of bile The rise of erythrosin is 3ULN
Glutamate aminotransferase and glutamate aminotransferase (AST and ALT)3ULN
Aptt 1.5ULN, and INR or PT1.5ULN
Fertile women must be willing to participate in the final CAPEOX programme during the study period and in conjunction with the triplezumab (JS001) Contraceptive measures were taken at least 120 days after administration, and urine or serum pregnancy tests were negative for 7 days prior to enrollment
Unsterilized male subjects must be willing to participate during the study and at the end of the triplezumab (JS001) combined CAPEOX regimen Use contraception for at least 120 days after the first dose
Good compliance, agreed to cooperate with the survival follow-up

Exclusion Criteria

Signs of distant metastasis
The presence of complete obstruction, massive bleeding, or perforation associated with a colon tumor
Previous use of immunocheckpoint inhibitors targeting ctla-4, pd-1 or pd-l1
Have radiotherapy plan before or after operation
A history of research on drug ingredients and severe allergic reactions to any monoclonal antibody
Severe infection in the active stage or poorly controlled clinically
Symptomatic congestive heart failure (New York heart association grade ii-iv) or symptomatic, poorly controlled arrhythmia often; Any arterial thromboembolic events that occurred or occurred within 6 months prior to inclusion included myocardial infarction, unstable angina cerebrovascular accident or transient ischemic attack; Deep vein thrombosis, pulmonary embolism, or any other serious condition occurred 3 months prior to enrollment, History of thromboembolism (implantable venous infusion port or catheter-induced thrombosis, or superficial venous thrombosis is not seen severe thromboembolism)
Subjects with any active, known or suspected autoimmune disease.History of autoimmune disease, including but not limited myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis related to antiphospholipid syndrome, wegener's granulomatosis, sjogren's syndrome, guillain-barre complex signs, multiple sclerosis, vasculitis, or glomerulonephritis
Patients with autoimmune hypothyroidism who receive stable dose hormone replacement therapy are eligible to participate in this study investigate
Patients with vitiligo or who have had complete remission of childhood asthma may be included without any intervention in adulthood
Asthma patients requiring intermittent use of bronchodilators, inhaled steroids, or topical injections were not excluded from the study outside
Use of corticosteroids (>10mg/ day prednisone or equivalent) or other within 14 days prior to initial administration subjects who received systemic therapy with immunosuppressive agents.In the absence of active autoimmune disease, inhalation or topical administration of corticosteroids and adrenal hormone replacement at dose 10mg/ day of prednisone
Subjects with highly suspected interstitial lung disease, or interstitial lung disease requiring steroid hormone therapy, or other severe cases were excluded diseases that seriously affect lung function
Get a live vaccine 4 weeks before joining
Patients with other active malignancies within 5 years prior to the first use of the study drug.Localized tumors that have been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc into the group
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