Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Jun 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced colon cancer that is classified as "MSS." The goal is to see how well combining chemotherapy (which helps kill cancer cells) with immunotherapy (a treatment that boosts the body's immune system to fight cancer) works before surgery. Researchers hope that this combination will help shrink the tumor and improve outcomes for patients.

To participate, individuals need to be between 18 and 75 years old, have a confirmed diagnosis of MSS colon cancer, and have a tumor that is positioned far enough from the anus. They should not have received any previous cancer treatments and must be able to tolerate chemotherapy. Participants can expect to receive a combination of treatments and will be closely monitored throughout the study. It's important for potential participants to understand the study and provide their consent before joining. If you or someone you know is interested, please consult with a healthcare provider to see if this trial might be a good option.

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Eligibility criteria

• 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.