Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer

Recruiting now · Phase 2

Conditions studied: Colon Neoplasm

In brief

This study aims to elucidate the regression effects of neoadjuvant chemotherapy combined with immunotherapy and adjuvant therapy in locally advanced MSS colon cancer.

Key facts

Study ID

NCT05914389

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

100

Starts

2023-08-01

Expected to finish

2030-08-01

Last updated by the study team

2023-08-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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