Immunotherapy-Chemo cocktail targets tough colon cancer before surgery
NCT ID NCT06124378
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 2 trial is testing whether adding the immunotherapy drug tislelizumab to standard chemotherapy (oxaliplatin and capecitabine) before surgery can help shrink tumors in people with a specific type of locally advanced colon cancer called microsatellite stable (MSS). About 60 participants will receive the combination for 2 to 4 cycles, then have surgery. The main goal is to see how many patients have no cancer cells left in their surgical specimen.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tislelizumab (Tevimbra) combined with oxaliplatin (Eloxatin) and capecitabine (Xeloda)
- What this could lead to
- If successful, this combination could become a new option to shrink tumors before surgery in patients with a hard-to-treat type of colon cancer.
- What could go wrong
- This is a small, early-phase study with no control group, so results may not apply broadly. The added immunotherapy could cause immune-related side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years old and ≤75 years old. * Pathologically diagnosed MSS ((confirmed by microsatellite stable detection or next-generation target sequencing) or (confirmed by immunohistochemistry)) 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 T4 or T1-4 N+ without multiple primary tumors or distant metastasis. * The Eastern Cooperative Oncology Group physical status score is 0-1. * Life expectancy is expected to be more than 1 year. * First diagnosis, no previous anti-tumor treatment received, and no chemotherapy contraindications. * Appropriate organ function is defined as follows: Hemoglobin level ≥ 60g/L, Neutrophil count ≥ 1.5×10\^9/L, Platelet count ≥ 75×10\^9/L, Serum total bilirubin ≤ 1.5× the upper limit of normal (UNL), Aspartate aminotransferase (AST) ≤ 2× UNL, Alanine aminotransferase (ALT) ≤ 3× UNL, Serum creatinine ≤ 1.5× UNL. * Informed consent, able to understand the study protocol and willing to participate in the study, and will provide written informed consent. Exclusion Criteria: * Enhanced CT stage (T1-3N0M0) * Multifocal colorectal cancer. * 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. * Tumor obstruction or high risk of obstruction, bleeding, and/or perforation requiring emergency surgery or stent placement. * Cannot tolerate chemotherapy or immunotherapy, such as but not limited to bone marrow suppression. * History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers. * Acute exacerbation of important organ diseases (such as but not limited to chronic obstructive pulmonary disease, coronary heart disease, and renal insufficiency) and/or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia, and myocarditis), American Society of Anesthesiologists score \> 3 points. * Mental disorders, illiteracy, or language communication barriers that prevent the understanding of the study protocol. * Peripheral sensory neuropathy, unable to receive oxaliplatin-based chemotherapy. * Continuous use of glucocorticoids for more than 3 days within 1 month prior to signing the informed consent form, or having comorbidities requiring the use of glucocorticoid therapy. * Unable to undergo enhanced CT examination * Pregnancy or lactation. * Refused to participate in this study. * Other situations in which the researcher deems unsuitable for this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
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