Combining chemotherapy and immunotherapy for advanced colon cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of neoadjuvant chemotherapy combined with immunotherapy in patients with locally advanced microsatellite stable (MSS) colon cancer. It aims to enhance tumor regression and improve long-term survival rates by using oxaliplatin and anti-PD-L1 monoclonal antibodies, along with the introduction of Clostridium butyricum to boost immune response. The study will screen patients for sensitivity to oxaliplatin and assess the efficacy of this combined treatment approach. By focusing on patients who have not received prior anti-tumor treatments, the study seeks to establish a new standard for neoadjuvant therapy in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Second Affiliated Hospital of Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Li Jun, MD
• Email: 2307016@zju.edu.cn
• Phone: +86 13777878061

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.