Locally Advanced Colon CancerPhase 3TORCH-C2NCT07877597
Chemotherapy Combined With or Without Short-Course Radiotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for High-Risk Locally Advanced Colon Cancer With pMMR/MSS
A Phase 3 study testing short-course radiotherapy, Serplulimab and CapOx(Capecitabine+ Oxaliplatin) in people with Locally Advanced Colon Cancer and pMMR, run by Fudan University at 1 site in China.
Trial summary
Locally advanced colon cancer, particularly T4 disease or colon cancer with bulky nodes, carries a poor prognosis and limited efficacy with neoadjuvant chemotherapy. In our previous small-sample phase II study, PD-1 inhibitor plus CAPOX chemotherapy combined with short-course radiotherapy yielded a marked improvement… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Colon Cancer, pMMR
- What is being tested?
- short-course radiotherapy, Serplulimab and CapOx(Capecitabine+ Oxaliplatin)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2026to 31 Dec 2031
- 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
- 1. Aged ≥18 years, of any gender. 2. Colon adenocarcinoma confirmed by histopathology, with the tumour located >15 cm from the anal verge on colonoscopy.
- 3. Locally high-risk disease demonstrated by contrast-enhanced abdominal CT or MRI, defined as tumour invasion beyond the serosa or into adjacent organs (cT4), or high-risk lymph nodes and tumour deposits. No distant metastasis (M0) identified on chest CT plus contrast-enhanced pelvic CT/MRI, or whole-body PET-CT.
- 4. pMMR or MSS status confirmed by immunohistochemistry or genetic testing. 5. No prior anti-tumour therapy. 6. ECOG performance status 0-1, with an expected survival of ≥3 months. Patients must be willing to cooperate with adverse event and efficacy assessments.
- 7. Adequate organ function:
- Neutrophils ≥1.5×10⁹/L; platelets ≥100×10⁹/L; haemoglobin ≥9 g/dL (or ≥9 g/dL after transfusion or supportive care); serum albumin ≥3 g/dL.
- Thyroid-stimulating hormone (TSH) ≤1×upper limit of normal (ULN), with T3 and T4 within normal ranges.
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- Bilirubin ≤1.5×ULN; ALT and AST ≤2×ULN.
- Serum creatinine ≤1.5×ULN; creatinine clearance ≥60 mL/min.
- International normalised ratio (INR) or prothrombin time (PT) ≤1.5×ULN, unless the patient is on anticoagulation with PT within the expected therapeutic range of the anticoagulant; activated partial thromboplastin time (aPTT) ≤1.5×ULN.
- 8. No severe concomitant disease that would limit life expectancy to less than 5 years.
- 9. Female subjects of childbearing potential must have a negative pregnancy test; female subjects without childbearing potential are also eligible.
- 10. Male patients of childbearing potential and female patients with childbearing potential and pregnancy risk must agree to use adequate contraception throughout the study period and for 12 months after completion of study treatment.
- 11. Signed and dated informed consent form, indicating that the patient has been informed of all relevant aspects of the study.
- 12. Patients who are willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
Who cannot join
- 1. Histopathological diagnosis of other colonic neoplasms, such as gastrointestinal stromal tumour, lymphoma, etc.
- 2. Prior treatment with PD-1 antibody, PD-L1 antibody or CTLA-4 antibody. 3. Previous or concurrent malignancy, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and papillary thyroid carcinoma.
- 4. Active autoimmune disease or a history of autoimmune disease (including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism). Exceptions include autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone; type 1 diabetes mellitus managed with stable-dose insulin; vitiligo; or childhood asthma/allergy that has resolved and requires no intervention in adulthood.
- 5. History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency disorders, or a history of solid organ transplantation and allogeneic bone marrow transplantation.
- 6. History of interstitial lung disease (excluding radiation pneumonitis not treated with steroids) or non-infectious pneumonitis.
- 7. Subjects with active pulmonary tuberculosis identified by medical history or CT scan; those with a history of active pulmonary tuberculosis within 1 year prior to enrollment; or those with a history of active pulmonary tuberculosis more than 1 year previously who did not receive standard anti-tuberculosis treatment.
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- 8. Subjects with active hepatitis B (HBV DNA ≥2000 IU/mL or 10⁴ copies/mL) or hepatitis C (positive hepatitis C antibody with HCV-RNA above the lower limit of quantification of the assay).
- 9. Severe impairment of cardiac, pulmonary, renal or hepatic function. 10. Uncontrolled hypertension despite antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
- 11. History of psychoactive substance abuse, alcoholism or illicit drug use. 12. Other factors judged by the investigator to compromise subject safety or trial compliance. Examples include severe diseases requiring concomitant treatment (including psychiatric disorders), significant laboratory abnormalities, or other familial or social factors.
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
Fudan University Shanghai Cancer Center
Shanghai, 200032
Zhen Zhang, MD, +86-021-64175590, zhen_zhang@fudan.edu.cn
Hui Zhang, MD, 18121299531, huizhang12@fudan.edu.cn
About this study
Official title: A Prospective, Randomized, Multicenter, Phase III Clinical Study of Chemotherapy Combined With or Without Short-Course Radiotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for High-Risk Locally Advanced Colon Cancer With pMMR/MSS (TORCH-C2 Trial)
Locally advanced colon cancer, particularly T4 disease or colon cancer with bulky nodes, carries a poor prognosis and limited efficacy with neoadjuvant chemotherapy. In our previous small-sample phase II study, PD-1 inhibitor plus CAPOX chemotherapy combined with short-course radiotherapy yielded a marked improvement in the pCR rate compared with neoadjuvant CAPOX alone, though survival outcomes remain under follow-up. This prospective, multicentre, randomised, three-arm phase III study enrolls 480 patients with pMMR/MSS locally advanced high-risk colon cancer. Participants are randomised in a 2:2:1 ratio to three arms: short-course radiotherapy combined with chemotherapy and PD-1 inhibitor (25 Gy in 5 fractions of radiotherapy, followed by 4 cycles of CAPOX plus the PD-1 inhibitor serplulimab); chemotherapy plus PD-1 inhibitor (4 cycles of CAPOX combined with serplulimab); and chemotherapy alone (4 cycles of CAPOX). The primary endpoint is the 3-year event-free survival (EFS) rate. Secondary endpoints include the pCR rate, 5-year overall survival rate (5y OS), R0 resection rate, toxicity, surgical complications and quality of life.
- Conditions
- Locally Advanced Colon Cancer, pMMR
- Being tested
- short-course radiotherapy, Serplulimab, CapOx(Capecitabine+ Oxaliplatin)
- Keywords
- colon cancer, radiotherapy, chemotherapy, immunotherapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short-course radiotherapyRadiation
short-course radiotherapy with 25 Gy in 5 Fractions (25 Gy/5Fx)
SerplulimabDrug
Also called immunotherapy, PD-1 inhibitor
A fixed dose of 300 mg is administered by intravenous infusion on Day 1 (D1), once every 3 weeks (Q3W).
CapOx(Capecitabine+ Oxaliplatin)Drug
Also called chemotherapy
Oxaliplatin (130 mg/m²) is administered by intravenous infusion on Day 1. Capecitabine 1000 mg/m² is given orally twice daily (bid) from Day 1 to Day 14, repeated every 3 weeks (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| Group A （chemoradiotherapy+pd-1） | Experimental | Group A receives 25 Gy in 5 fractions of radiotherapy, followed by 4 cycles of CAPOX plus the PD-1 inhibitor serplulimab Receives: Radiation: short-course radiotherapy; Drug: Serplulimab; Drug: CapOx(Capecitabine+ Oxaliplatin) |
| Group B (immunochemotherapy) | Experimental | Group B receives 4 cycles of CAPOX plus the PD-1 inhibitor serplulimab Receives: Drug: Serplulimab; Drug: CapOx(Capecitabine+ Oxaliplatin) |
| Group C (chemotherapy) | Active comparator | Group C receives 4 cycles of CAPOX Receives: Drug: CapOx(Capecitabine+ Oxaliplatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year event-free survival
rate of 3-year event-free survival
Measured: From the date of randomization until the date of first documented disease progression or toxicity during neoadjuvant therapy that prevent surgery, local regional recurrence, distant metastasis, or death, whichever came first, assessed up to 36 months.
Secondary outcomes (6)
pathological complete response （pCR）
Defined as the proportion of patients in the arm with no residual viable tumour cells in the primary lesion and lymph nodes on surgical specimens.
Measured: one month after surgery
R0 resection rate
Defined as the proportion of patients in the trial arm who achieve curative resection with microscopically negative resection margins.
Measured: one month after surgery
Organ preservation rate:
Defined as the proportion of patients in the trial arm without combined organ resection.
Measured: one month after surgery
5-year overall survival
Defined as the proportion of patients in the trial arm who are still alive at 5 years from randomisation.
Measured: From the time of randomisation to 5 years.
Grade ≥3 toxicity rate
Defined as the proportion of all enrolled patients who experience grade 3 or higher adverse events related to radiotherapy, chemotherapy and immunotherapy during and after the combined treatment.
Measured: From the time of randomization to 1 year after complete treatment
Surgical complication rate
Defined as the proportion of operated patients who develop surgical-related complications including wound infection, anastomotic leak, haemorrhage and others after surgery.
Measured: From the time of surgery to 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Colon CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Zhang, Fudan University
- Investigators
- Zhen Zhang, MD, Principal investigator, Fudan UniversitySanjun Cai, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877597
- Sponsor's protocol ID
- FDRT-2026-404-5256
- Acronym
- TORCH-C2
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be shared. The rationale includes restrictions imposed by the institutional review board, Chinese national data protection regulations, and patient privacy requirements. In addition, the study dataset contains sensitive clinical and genomic information of participants, and the research team has not established a dedicated data sharing platform for external IPD access. Study summary results will be published in peer-reviewed journals upon completion of the trial.
Publications
Zhao J, Zhang H, Yu L, Hu Y, Yang Y, Dong S, Mi J, Fang Y, Qiao J, Xia F, Hu W, Zhang Z. Diagnostic CT-guided online adaptive radiotherapy for locally advanced colon cancer: a prospective implementation and feasibility study. Clin Transl Radiat Oncol. 2026 Apr 16;59:101162. doi: 10.1016/j.ctro.2026.101162. eCollection 2026 Jul.
PubMed 42028346Hu H, Zhang J, Li Y, Wang X, Wang Z, Wang H, Kang L, Liu P, Lan P, Wu X, Zhen Y, Pei H, Huang Z, Zhang H, Chen W, Zeng Y, Lai J, Wei H, Huang X, Chen J, Chen J, Tao K, Xu Q, Peng X, Liang J, Cai G, Ding K, Ding Z, Hu M, Zhang W, Tang B, Hong C, Cao J, Huang Z, Cao W, Li F, Wang X, Wang C, Huang Y, Zhao Y, Cai Y, Ling J, Xie X, Wu Z, Shi L, Ling L, Liu H, Wang J, Huang M, Deng Y; OPTICAL study group. Neoadjuvant Chemotherapy With Oxaliplatin and Fluoropyrimidine Versus Upfront Surgery for Locally Advanced Colon Cancer: The Randomized, Phase III OPTICAL Trial. J Clin Oncol. 2024 Sep 1;42(25):2978-2988. doi: 10.1200/JCO.23.01889. Epub 2024 Apr 2.
PubMed 38564700Foxtrot Collaborative Group. Feasibility of preoperative chemotherapy for locally advanced, operable colon cancer: the pilot phase of a randomised controlled trial. Lancet Oncol. 2012 Nov;13(11):1152-60. doi: 10.1016/S1470-2045(12)70348-0. Epub 2012 Sep 25.
PubMed 23017669
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter, Phase III Clinical Study of Chemotherapy Combined With or Without Short-Course Radiotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for High-Risk Locally Advanced Colon Cancer With pMMR/MSS (TORCH-C2 Trial)
- ClinicalTrials.gov ID
- NCT07877597
- Acronym / sponsor ID
- TORCH-C2 / FDRT-2026-404-5256
- Conditions
- Locally Advanced Colon Cancer, pMMR
- Keywords
- colon cancer, radiotherapy, chemotherapy, immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 16 Oct 2026 (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.
Locally advanced colon cancer, particularly T4 disease or colon cancer with bulky nodes, carries a poor prognosis and limited efficacy with neoadjuvant chemotherapy. In our previous small-sample phase II study, PD-1 inhibitor plus CAPOX chemotherapy combined with short-course radiotherapy yielded a marked improvement in the pCR rate compared with neoadjuvant CAPOX alone, though survival outcomes remain under follow-up. This prospective, multicentre, randomised, three-arm phase III study enrolls 480 patients with pMMR/MSS locally advanced high-risk colon cancer. Participants are randomised in a 2:2:1 ratio to three arms: short-course radiotherapy combined with chemotherapy and PD-1 inhibitor (25 Gy in 5 fractions of radiotherapy, followed by 4 cycles of CAPOX plus the PD-1 inhibitor serplulimab); chemotherapy plus PD-1 inhibitor (4 cycles of CAPOX combined with serplulimab); and chemotherapy alone (4 cycles of CAPOX). The primary endpoint is the 3-year event-free survival (EFS) rate. Secondary endpoints include the pCR rate, 5-year overall survival rate (5y OS), R0 resection rate, toxicity, surgical complications and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A （chemoradiotherapy+pd-1） | Experimental | Radiation: short-course radiotherapy, Drug: Serplulimab, Drug: CapOx(Capecitabine+ Oxaliplatin)Group A receives 25 Gy in 5 fractions of radiotherapy, followed by 4 cycles of CAPOX plus the PD-1 inhibitor serplulimab |
| Group B (immunochemotherapy) | Experimental | Drug: Serplulimab, Drug: CapOx(Capecitabine+ Oxaliplatin)Group B receives 4 cycles of CAPOX plus the PD-1 inhibitor serplulimab |
| Group C (chemotherapy) | Active comparator | Drug: CapOx(Capecitabine+ Oxaliplatin)Group C receives 4 cycles of CAPOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1. Aged ≥18 years, of any gender. 2. Colon adenocarcinoma confirmed by histopathology, with the tumour located >15 cm from the anal verge on colonoscopy.
- 3. Locally high-risk disease demonstrated by contrast-enhanced abdominal CT or MRI, defined as tumour invasion beyond the serosa or into adjacent organs (cT4), or high-risk lymph nodes and tumour deposits. No distant metastasis (M0) identified on chest CT plus contrast-enhanced pelvic CT/MRI, or whole-body PET-CT.
- 4. pMMR or MSS status confirmed by immunohistochemistry or genetic testing. 5. No prior anti-tumour therapy. 6. ECOG performance status 0-1, with an expected survival of ≥3 months. Patients must be willing to cooperate with adverse event and efficacy assessments.
- 8. No severe concomitant disease that would limit life expectancy to less than 5 years.
- 9. Female subjects of childbearing potential must have a negative pregnancy test; female subjects without childbearing potential are also eligible.
Key exclusion criteria (9 listed)
- 1. Histopathological diagnosis of other colonic neoplasms, such as gastrointestinal stromal tumour, lymphoma, etc.
- 2. Prior treatment with PD-1 antibody, PD-L1 antibody or CTLA-4 antibody. 3. Previous or concurrent malignancy, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and papillary thyroid carcinoma.
- 4. Active autoimmune disease or a history of autoimmune disease (including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism). Exceptions include autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone; type 1 diabetes mellitus managed with stable-dose insulin; vitiligo; or childhood asthma/allergy that has resolved and requires no intervention in adulthood.
- 5. History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency disorders, or a history of solid organ transplantation and allogeneic bone marrow transplantation.
- 6. History of interstitial lung disease (excluding radiation pneumonitis not treated with steroids) or non-infectious pneumonitis.
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 |
|---|---|---|
| short-course radiotherapyshort-course radiotherapy with 25 Gy in 5 Fractions (25 Gy/5Fx) | Radiation | Group A （chemoradiotherapy+pd-1） |
| SerplulimabAlso: immunotherapy, PD-1 inhibitorA fixed dose of 300 mg is administered by intravenous infusion on Day 1 (D1), once every 3 weeks (Q3W). | Drug | Group A （chemoradiotherapy+pd-1）, Group B (immunochemotherapy) |
| CapOx(Capecitabine+ Oxaliplatin)Also: chemotherapyOxaliplatin (130 mg/m²) is administered by intravenous infusion on Day 1. Capecitabine 1000 mg/m² is given orally twice daily (bid) from Day 1 to Day 14, repeated every 3 weeks (Q3W). | Drug | Group A （chemoradiotherapy+pd-1）, Group B (immunochemotherapy), Group C (chemotherapy) |
Primary outcome
3-year event-free survival
Time frame: From the date of randomization until the date of first documented disease progression or toxicity during neoadjuvant therapy that prevent surgery, local regional recurrence, distant metastasis, or death, whichever came first, assessed up to 36 months.
rate of 3-year event-free survival
6 secondary outcomes
pathological complete response （pCR）
Time frame: one month after surgery
R0 resection rate
Time frame: one month after surgery
Organ preservation rate:
Time frame: one month after surgery
5-year overall survival
Time frame: From the time of randomisation to 5 years.
Grade ≥3 toxicity rate
Time frame: From the time of randomization to 1 year after complete treatment
Surgical complication rate
Time frame: From the time of surgery to 1 month after surgery
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 16 Oct 2026.
- Background: PubMed 42028346Zhao J, Zhang H, Yu L, Hu Y, Yang Y, Dong S, Mi J, Fang Y, Qiao J, Xia F, Hu W, Zhang Z. Diagnostic CT-guided online adaptive radiotherapy for locally advanced colon cancer: a prospective implementation and feasibility study. Clin Transl Radiat Oncol. 2026 Apr 16;59:101162. doi: 10.1016/j.ctro.2026.101162. eCollection 2026 Jul.
- Background: PubMed 38564700Hu H, Zhang J, Li Y, Wang X, Wang Z, Wang H, Kang L, Liu P, Lan P, Wu X, Zhen Y, Pei H, Huang Z, Zhang H, Chen W, Zeng Y, Lai J, Wei H, Huang X, Chen J, Chen J, Tao K, Xu Q, Peng X, Liang J, Cai G, Ding K, Ding Z, Hu M, Zhang W, Tang B, Hong C, Cao J, Huang Z, Cao W, Li F, Wang X, Wang C, Huang Y, Zhao Y, Cai Y, Ling J, Xie X, Wu Z, Shi L, Ling L, Liu H, Wang J, Huang M, Deng Y; OPTICAL study group. Neoadjuvant Chemotherapy With Oxaliplatin and Fluoropyrimidine Versus Upfront Surgery for Locally Advanced Colon Cancer: The Randomized, Phase III OPTICAL Trial. J Clin Oncol. 2024 Sep 1;42(25):2978-2988. doi: 10.1200/JCO.23.01889. Epub 2024 Apr 2.
- Background: PubMed 23017669Foxtrot Collaborative Group. Feasibility of preoperative chemotherapy for locally advanced, operable colon cancer: the pilot phase of a randomised controlled trial. Lancet Oncol. 2012 Nov;13(11):1152-60. doi: 10.1016/S1470-2045(12)70348-0. Epub 2012 Sep 25.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be shared. The rationale includes restrictions imposed by the institutional review board, Chinese national data protection regulations, and patient privacy requirements. In addition, the study dataset contains sensitive clinical and genomic information of participants, and the research team has not established a dedicated data sharing platform for external IPD access. Study summary results will be published in peer-reviewed journals upon completion of the trial.
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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.
Zhen Zhang, MD principal investigator
Fudan University
Sanjun Cai, MD principal investigator
Fudan 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 short-course radiotherapy, Serplulimab and CapOx(Capecitabine+ Oxaliplatin) in people with Locally Advanced Colon Cancer and pMMR, run by Fudan 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 14 inclusion and 9 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 16 Oct 2026. 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 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 Zhen Zhang, MD (+86-021-64175590, zhen_zhang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year event-free survival (time frame: From the date of randomization until the date of first documented disease progression or toxicity during neoadjuvant therapy that prevent surgery, local regional recurrence, distant metastasis, or death, whichever came first, assessed up to 36 months.). 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 NCT07877597, which also lists 3 linked publications.
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 16 Oct 2026.