AzTrials
AzTrials

Colonic NeoplasmsPhase 2NCT06124378

Neoadjuvant Tislelizumab With Chemotherapy for the Treatment of MSS Colon Cancer

A Phase 2 study testing Tislelizumab, Oxaliplatin and Capecitabine in people with Colonic Neoplasms and Neoadjuvant Therapy, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study aims to elucidate the effects of neoadjuvant Tislelizumab combined with chemotherapy in locally advanced Microsatellite Stable (MSS) colon cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Tislelizumab, Oxaliplatin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
13 Nov 2023to 30 Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

Other trials in China

About this study

Official title: Neoadjuvant Tislelizumab With Oxaliplatin and Capecitabine in Microsatellite Stable, Locally Advanced Colon Cancer (NETSAC): A Single-arm, Single-center, Exploratory Phase II Clinical Study

This study aims to elucidate the effects of neoadjuvant Tislelizumab combined with chemotherapy in locally advanced Microsatellite Stable (MSS) colon cancer.

Read the detailed description

The standard treatment for locally advanced colon cancer is complete mesocolic excision (CME) followed by adjuvant chemotherapy. The MOSAIC and 16968 studies have shown that about 30% of patients experience recurrence and metastasis within 6-7 years after surgery. Neoadjuvant chemotherapy may improve the prognosis of colon cancer patients. The significant tumor remission after neoadjuvant therapy probably indicates a better long-term survival for patients. The OPTICAL and Fluoropyrimidine Oxaliplatin and Targeted Receptor Pre-Operative Therapy (FoxTROT) studies have shown that approximately 35% of patients are resistant to oxaliplatin-containing neoadjuvant chemotherapy, with a pathological complete response (pCR) rate of less than 10% and uncertain survival improvement. Moreover, previous study shown that immunotherapy has unsatisfied efficacy for microsatellite stable (MSS) colon cancer. Therefore, it is necessary to explore more effective neoadjuvant treatment strategy for tumor therapy.

Immunogenic cell death will be enhanced by oxaliplatin-induced immunogenicity and combined with anti-programmed cell death 1 (PD-1) monoclonal antibodies for neoadjuvant therapy. The study will conduct 2 or 4 cycles of Tislelizumab with Oxaliplatin and Capecitabine, followed by CME surgery. The study's primary endpoint is the proportion of pCR in the pathological specimens of surgically resected tumors.

Being tested
Tislelizumab, Oxaliplatin, Capecitabine, Colectomy
Keywords
Colon cancer, Neoadjuvant chemotherapy; PD-1 inhibitor
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TislelizumabDrug

    Also called Tevimbra

    200 mg on Day 1 every 3 weeks and repeat for 2 or 4 cycles. The incidence of adverse events with Tislelizumab is relatively low. The Tislelizumab dose adjustment was implemented according to the prescribing information.

  • OxaliplatinDrug

    Also called Eloxatin

    Oxaliplatin 130mg/m2 on Day 1 every 3 weeks and repeat for 2 or 4 cycles. The dose reduction protocol for oxaliplatin-induced toxicity was implemented according to the study in British Journal of Cancer (2018) 118:1322-1328.

  • CapecitabineDrug

    Also called Xeloda

    Oral Capecitabine 1000 mg/m2 twice daily combined with oxaliplatin chemotherapy from Day 1 to Day 14 every 3 weeks and repeat for 2 or 4 cycles. The dose reduction protocol for capecitabine-induced toxicity was implemented according to the study in British Journal of Cancer (2018) 118:1322-1328.

  • ColectomyProcedure or surgery

    Also called Surgery

    The specific surgical approach is laparoscopic. The tumor blood supply is ligated and cut at the root of the mesentery, and the margin of resection should be no less than 10cm. Complete resection of the mesocolon (CME) is performed in conjunction.

Study groups in NCT06124378
Study groupRoleWhat they receive
Tislelizumab combined with Oxaliplatin and Capecitabine cohortExperimentalPatients with locally advanced colon cancer who met the inclusion criteria received two or four cycles of Tislelizumab combined Capecitabine and Oxaliplatin regimen chemotherapy and were evaluated by enhanced CT. Then, these patients will receive curative surgery for colon cancer. Interventions: Drug: Oxaliplatin,130mg/m2 for chemotherapy on Day 1 every 3 weeks and repeat for 2 or 4 cycles. Drug: Capecitabine, Oral Capecitabine 1000 mg/m2 twice daily from Day 1 to Day 14 every 3 weeks and repeat for 2 or 4 cycles. Drug: Tislelizumab, 200 mg on Day 1 every 3 weeks and repeat for 2 or 4 cycles. Procedure: Colectomy
Receives: Drug: Tislelizumab; Drug: Oxaliplatin; Drug: Capecitabine; Procedure: Colectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pCR

    the proportion of tumor regression grades 0 (TRG0, disappearance of tumor cells) in the pathological specimens of surgically resected tumors.

    Measured: 3-5 days of postoperative pathological examination

Secondary outcomes (8)

  1. R0 resection

    the rate of a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.

    Measured: 3-5 days of postoperative pathological examination

  2. Disease-free survival (DFS)

    3-year disease-free survival

    Measured: 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.

  3. Overall survival (OS)

    3-year overall survival

    Measured: From the date of the patient signs the informed consent form until the date of the patient's death, assessed up to 36 months.

  4. Adverse events (AEs)

    the rate of adverse events

    Measured: up to half a year

  5. Immune-related adverse events (irAEs)

    the rate of immune-related adverse events

    Measured: up to half a year

  6. Surgical complication

    the rate of surgical complication during or after operation.

    Measured: From the day of surgery to 30 days after the operation, including intraoperative and postoperative complications.

  7. T lymphocyte

    Cells with cellular immune function. The types and counts of T cells are analyzed using flow cytometry.

    Measured: up to 3 months after surgery.

  8. Gene mutation signatures of colon cancer

    Next-generation target sequencing is performed to analyze the gene mutation signatures.

    Measured: up to 3 months before surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2023
  2. Study start13 Nov 2023
  3. Primary completion28 Feb 2025
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06124378
Sponsor's protocol ID
Minglin Lin
Status last verified
Sep 2025
First submitted
4 Nov 2023
Last updated
24 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab, Oxaliplatin and Capecitabine in people with Colonic Neoplasms and Neoadjuvant Therapy, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR (time frame: 3-5 days of postoperative pathological examination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06124378.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in