Colon Neoplasm Clinical Trial
— ICONICOfficial title:
Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer: a Prospective Single-center Multi-arm Open-label Randomized Phase II Study
NCT number | NCT05914389 |
Other study ID # | 2023-0296 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | August 2023 |
Est. completion date | August 2030 |
This study aims to elucidate the regression effects of neoadjuvant chemotherapy combined with immunotherapy and adjuvant therapy in locally advanced MSS colon cancer.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | August 2030 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age =18 years old and =75 years old. - Pathologically diagnosed MSS or pMMR-type colon adenocarcinoma. - The lower edge of the tumor is more than 12cm from the anus as measured by colonoscopy and the lower edge of the tumor cannot be directly palpated during rectal examination. - Enhanced CT stage T3/4 or T1-4N+ without multiple primary tumors or distant metastasis. - Life expectancy is expected to be more than 1 year. - First diagnosis, no previous anti-tumor treatment received, and no chemotherapy contraindications. - Informed consent, able to understand the study protocol and willing to participate in the study, and will provide written informed consent. Exclusion Criteria: - Refused to participate in this study. - Multifocal colorectal cancer. - History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers. - Cannot tolerate chemotherapy, such as but not limited to bone marrow suppression. - Acute exacerbation of important organ diseases (such as but not limited to COPD, coronary heart disease, and renal insufficiency) and/or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia, and myocarditis), ASA score > 3 points. - Mental disorders, illiteracy, or language communication barriers that prevent the understanding of the study protocol. - Tumor obstruction or high risk of obstruction, bleeding, and/or perforation. - Peripheral sensory neuropathy, unable to receive oxaliplatin-based chemotherapy. - Pregnancy or lactation. - Unable to undergo enhanced CT examination or having comorbidities requiring the use of glucocorticoid therapy. - Continuous use of glucocorticoids for more than 3 days within 1 month prior to signing the informed consent form. - CT or MRI in the mid-sagittal plane shows that the lower border of the tumor is below the line connecting the sacrococcygeal promontory and the upper border of the pubic symphysis. - Other situations in which the researcher deems unsuitable for this study. |
Country | Name | City | State |
---|---|---|---|
China | Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TRG0/1 | The sum of tumor regression grades TRG0(disappearance of tumor) and TRG1(scattered residual tumor)(AJCC standard). | 1 day of postoperative pathological examination. | |
Secondary | AE | the rate of adverse event(AE). | Adverse events (NCI CTC AE 5.0) that occurred from the first day of induction chemotherapy to one day before the surgery date(up to half a year). | |
Secondary | Surgical Complication | the rate of surgical complication during or after operation. | From the day of surgery to 30 days after the operation, including intraoperative and postoperative complications. | |
Secondary | DFS | 3-year Disease-free survival. | From date of the patient signs the informed consent form until the date of earliest occurrence of the patient's tumor recurrence or death,whichever came first, assessed up to 36 months. | |
Secondary | OS | 5-year Overall survival. | From the date of the patient signs the informed consent form until the date of the patient's death, assessed up to 60 months. | |
Secondary | Concentration of FLT3L | Fms Related Receptor Tyrosine Kinase 3 Ligand is a marker of immunogenic cell death. | blood tests for FLT3LG at initial diagnosis, after induction chemotherapy, before and 3 months after surgery. | |
Secondary | Concentration of cytokines | Blood density measurement of immunoreaction associated cytokines. | Blood tests of cytokines such as IFN-? are conducted using techniques such as immunofluorescence and ELISA at initial diagnosis, after induction chemotherapy, before and 3 months after surgery. | |
Secondary | T lymphocyte | Cells with cellular immune function. | The types and counts of T cells are analyzed using flow cytometry at initial diagnosis, after induction chemotherapy, before surgery, and 3 months after surgery. | |
Secondary | Molecular pathological analysis of tumor tissue. | Whole exome sequencing and Nanostring to analyze changes in the tumor microenvironment immune status. | Nanostring and Whole exome gene sequencing is performed on tumor specimens to analyze the changes in immune cell types, counts, and other immune status-related factors in the tumor microenvironment before and after treatment (up to half a year). | |
Secondary | Minimal Residual Disease (MRD) | Minimal Residual Disease which is a potential source of tumor recurrence and distant metastasis. | Collect plasma after surgery for MRD detection (up to half a year). |
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