Colonic NeoplasmsPhase 3NCT07132008
Neoadjuvant CAPOX Plus Tislelizumab vs CAPOX in MSS High-Risk Locally Advanced Colon Cancer
A Phase 3 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.
Trial summary
Building on earlier exploratory work, this study further designs a multi-institutional, prospective, randomized clinical trial to evaluate the efficacy and safety of the combination therapy of the immune checkpoint inhibitor Tislelizumab with CAPOX for neoadjuvant treatment in high-risk locally advanced MSS-type… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonic Neoplasms, Neoadjuvant Therapy, Immune Checkpoint Inhibitors
- What is being tested?
- Tislelizumab, Oxaliplatin and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 30 Sep 2030
- Phase
- Phase 3
- 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.
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- 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.
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- 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. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
About this study
Official title: Prospective, Multicenter, Randomized Trial of Neoadjuvant Capecitabine and Oxaliplatin (CAPOX) Plus Tislelizumab Versus CAPOX in Microsatellite Stable High-risk Locally Advanced Colon Cancer
Building on earlier exploratory work, this study further designs a multi-institutional, prospective, randomized clinical trial to evaluate the efficacy and safety of the combination therapy of the immune checkpoint inhibitor Tislelizumab with CAPOX for neoadjuvant treatment in high-risk locally advanced MSS-type colorectal cancer, as well as its impact on patient outcomes. This study aims to provide new evidence for the clinical practice of treating MSS-type colorectal cancer.
Read the detailed description
Patients were randomly assigned to either the experimental group, receiving neoadjuvant therapy with Tislelizumab combined with CAPOX, or the control group, receiving neoadjuvant CAPOX chemotherapy alone. Patients in the experimental group underwent four cycles of neoadjuvant CAPOX chemotherapy plus Tislelizumab prior to surgery. Patients in the control group received four cycles of neoadjuvant CAPOX chemotherapy alone. Patients deemed eligible for R0 resection based on radiographic assessment proceeded to radical colorectal cancer surgery. Following surgery, patients in both groups were to complete an additional four cycles of CAPOX chemotherapy. We compared and analyzed the short- and long-term clinical outcomes between the Tislelizumab plus CAPOX regimen and CAPOX alone for the treatment of microsatellite stable (MSS)-type high-risk locally advanced colon cancer (stages T4NanyM0 or TanyN+M0).
- Being tested
- Tislelizumab, Oxaliplatin, Capecitabine
- 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 Baizean
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.
| Study group | Role | What they receive |
|---|---|---|
| CAPOX combined with Tislelizumab | Experimental | Patients in the experimental group underwent two or four cycles of preoperative CAPOX combined with Tislelizumab. Patients assessed as suitable for R0 resection by imaging underwent radical colectomy. Following surgery, all patients in both groups completed an additional four or six cycles of adjuvant CAPOX chemotherapy. Receives: Drug: Tislelizumab; Drug: Oxaliplatin; Drug: Capecitabine |
| CAPOX chemotherapy | Placebo comparator | Patients in the experimental group underwent two or four cycles of preoperative CAPOX combined with placebo. Patients assessed as suitable for R0 resection by imaging underwent radical colectomy. Following surgery, all patients in both groups completed an additional four or six cycles of adjuvant CAPOX chemotherapy. Receives: Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (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 (6)
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
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.
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.
Adverse events (AEs)
the rate of adverse events
Measured: up to half a year
Immune-related adverse events (irAEs)
the rate of immune-related adverse events
Measured: up to half a year
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital of University of South China
- Responsible party
- Sponsor
- Investigators
- Sen Zhang, Study director, First Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132008
- Sponsor's protocol ID
- 2025-K0173
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Trial of Neoadjuvant Capecitabine and Oxaliplatin (CAPOX) Plus Tislelizumab Versus CAPOX in Microsatellite Stable High-risk Locally Advanced Colon Cancer
- ClinicalTrials.gov ID
- NCT07132008
- Acronym / sponsor ID
- 2025-K0173
- Keywords
- Colon cancer, Neoadjuvant chemotherapy, PD-1 inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital of University of South China
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Building on earlier exploratory work, this study further designs a multi-institutional, prospective, randomized clinical trial to evaluate the efficacy and safety of the combination therapy of the immune checkpoint inhibitor Tislelizumab with CAPOX for neoadjuvant treatment in high-risk locally advanced MSS-type colorectal cancer, as well as its impact on patient outcomes. This study aims to provide new evidence for the clinical practice of treating MSS-type colorectal cancer.
Detailed description
Patients were randomly assigned to either the experimental group, receiving neoadjuvant therapy with Tislelizumab combined with CAPOX, or the control group, receiving neoadjuvant CAPOX chemotherapy alone. Patients in the experimental group underwent four cycles of neoadjuvant CAPOX chemotherapy plus Tislelizumab prior to surgery. Patients in the control group received four cycles of neoadjuvant CAPOX chemotherapy alone. Patients deemed eligible for R0 resection based on radiographic assessment proceeded to radical colorectal cancer surgery. Following surgery, patients in both groups were to complete an additional four cycles of CAPOX chemotherapy. We compared and analyzed the short- and long-term clinical outcomes between the Tislelizumab plus CAPOX regimen and CAPOX alone for the treatment of microsatellite stable (MSS)-type high-risk locally advanced colon cancer (stages T4NanyM0 or TanyN+M0).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAPOX combined with Tislelizumab | Experimental | Drug: Tislelizumab, Drug: Oxaliplatin, Drug: CapecitabinePatients in the experimental group underwent two or four cycles of preoperative CAPOX combined with Tislelizumab. Patients assessed as suitable for R0 resection by imaging underwent radical colectomy. Following surgery, all patients in both groups completed an additional four or six cycles of adjuvant CAPOX chemotherapy. |
| CAPOX chemotherapy | Placebo comparator | Drug: Oxaliplatin, Drug: CapecitabinePatients in the experimental group underwent two or four cycles of preoperative CAPOX combined with placebo. Patients assessed as suitable for R0 resection by imaging underwent radical colectomy. Following surgery, all patients in both groups completed an additional four or six cycles of adjuvant CAPOX chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabAlso: Baizean200 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. | Drug | CAPOX combined with Tislelizumab |
| OxaliplatinAlso: EloxatinOxaliplatin 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. | Drug | CAPOX chemotherapy, CAPOX combined with Tislelizumab |
| CapecitabineAlso: XelodaOral 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. | Drug | CAPOX chemotherapy, CAPOX combined with Tislelizumab |
Primary outcome
Pathological complete response (pCR)
Time frame: 3-5 days of postoperative pathological examination
the proportion of tumor regression grades 0 (TRG0, disappearance of tumor cells) in the pathological specimens of surgically resected tumors.
6 secondary outcomes
R0 resection
Time frame: 3-5 days of postoperative pathological examination
Disease-free survival (DFS)
Time frame: 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.
Overall survival (OS)
Time frame: From the date of the patient signs the informed consent form until the date of the patient's death, assessed up to 36 months.
Adverse events (AEs)
Time frame: up to half a year
Immune-related adverse events (irAEs)
Time frame: up to half a year
Surgical complication
Time frame: From the day of surgery to 30 days after the operation, including intraoperative and postoperative complications.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sen Zhang study director
First Affiliated Hospital of Guangxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 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: opening soon, as of the sponsor's last update on 20 Aug 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Minglin Lin (+86-771-5356529, linminglin@sr.gxmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (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?
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 20 Aug 2025.