Neoadjuvant TherapiesPhase 2MODIFI-CCNCT07230639
Node-Sparing Hypofractionated Radiotherapy Plus Chemotherapy and PD-1 Inhibitor in pMMR/MSS High-Risk Locally Advanced Colon Cancer: A Prospective, Randomized, Phase II Trial
A Phase 2 study testing Node-Sparing Radiotherapy(25Gy/5F) plus Chemotherapy and PD-1 inhibitor and Node-Sparing Radiotherapy(24Gy/4F) plus Chemotherapy and PD-1 inhibitor in people with Neoadjuvant Therapies and Immune Checkpoint Therapy, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Most colorectal cancers are microsatellite stable (MSS) or mismatch repair-proficient (pMMR) subtypes, which show limited efficacy to PD-1 inhibitors. Radiotherapy can enhance the release of tumor-associated antigens, thereby improving the responsiveness of pMMR/MSS colorectal cancers to PD-1 blockade. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoadjuvant Therapies, Immune Checkpoint Therapy, Radiotherapy
- What is being tested?
- Node-Sparing Radiotherapy(25Gy/5F) plus Chemotherapy and PD-1 inhibitor and Node-Sparing Radiotherapy(24Gy/4F) plus Chemotherapy and PD-1 inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2025to 31 Dec 2031
- 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
- Voluntarily signs a written informed consent form.
- Age ≥ 18 and ≤ 75 years at enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy > 2 years.
- Histologically confirmed colon adenocarcinoma (without squamous or sarcomatoid components).
- Tumor biopsy by immunohistochemistry indicating pMMR, i.e., MLH1, MSH2, MSH6, and PMS2 all positive, or genomic testing indicating MSS.
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- Per AJCC 8th edition, imaging (contrast-enhanced CT or contrast-enhanced MRI) shows T4 and/or N+ disease (stage IIB-III).
- Prior to enrollment, the subject must be evaluated by a surgery attending physician responsible for the operation, based on medical history, to confirm eligibility for R0 resection with curative intent.
- No prior systemic or local antitumor therapy for rectal cancer before study treatment, including radiotherapy, chemotherapy, immunotherapy, biologics, or small-molecule targeted therapy.
- Subject agrees to collection and study use of required tumor tissue and peripheral blood specimens during screening and throughout the study.
- Adequate organ function:
- Hematologic (no blood components or hematopoietic growth factors within 7 days before starting study treatment): i. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L (1,500/mm³); ii. Platelets ≥ 100 × 10⁹/L (100,000/mm³); iii. Hemoglobin ≥ 90 g/L. b) Renal: i. Calculated creatinine clearance (CrCl) ≥ 50 mL/min using the Cockcroft-Gault formula: CrCl (mL/min) = {(140 - age) × weight (kg) × 0.85} / [72 × serum creatinine (mg/dL)] ii. Urine protein < 2+ or 24-hour urine protein < 1.0 g. c) Hepatic: i. Total bilirubin (TBil) ≤ 1.5 × ULN; ii. AST and ALT ≤ 2.5 × ULN; iii. Serum albumin (ALB) ≥ 28 g/L. d) Coagulation: i. INR and aPTT ≤ 1.5 × ULN. e) Cardiac: i. Left ventricular ejection fraction (LVEF) ≥ 50%.
- Women of childbearing potential (WOCBP) must have a urine or serum pregnancy test within 3 days prior to starting study treatment (if the urine test cannot be definitively interpreted as negative, a serum test is required; the serum result prevails) and the result must be negative. If a WOCBP has sexual intercourse with a non-sterilized male partner, she must begin using an acceptable contraceptive method from screening and agree to continue contraception for 120 days after the last dose of study drug; whether contraception can be discontinued thereafter should be discussed with the investigator. Periodic abstinence and calendar/rhythm methods are unacceptable.
- WOCBP are defined as females who have not undergone surgical sterilization (i.e., bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) and have not been postmenopausal (amenorrhea for ≥12 consecutive months without an alternative medical cause, with serum FSH in the postmenopausal range).
- A highly effective method of contraception is one with a low failure rate when used consistently and correctly (e.g., <1% per year). Not all methods are highly effective. Barrier methods alone are not acceptable; WOCBP must at minimum use a hormonal contraceptive (e.g., oral contraceptives) to ensure no pregnancy occurs.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study requirements.
- ------
Who cannot join
- Suspicious metastatic lesions or the presence of unresectable locally advanced disease, regardless of stage.
- Malignancy other than colorectal cancer within 5 years prior to enrollment. Subjects cured by local therapy for other malignancies (e.g., basal or squamous cell skin cancer, superficial bladder cancer, ductal carcinoma in situ) are not excluded.
- Receipt of any investigational drug or device within 4 weeks prior to the first dose of study drug.
- Intestinal obstruction, perforation, gastrointestinal bleeding, or other conditions requiring emergency surgery.
- Multiple primary colorectal cancers.
- Prior radiotherapy to the pelvis or abdomen.
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- Inability to swallow tablets, malabsorption syndrome, or any condition that affects gastrointestinal absorption.
- Any prior systemic or local antitumor therapy for locally advanced colon cancer, including curative surgery, chemotherapy, radiotherapy, immunotherapy (including immune checkpoint inhibitors/agonists or cellular immunotherapy), biologics, or small-molecule targeted therapy.
- Nonspecific immunomodulatory therapy within 2 weeks before study treatment (e.g., interleukins, interferons, thymosin, tumor necrosis factor; excluding IL-11 used for thrombocytopenia); antitumor-indicated traditional Chinese herbal medicines or patent medicines within 1 week before study treatment.
- Active autoimmune disease requiring systemic therapy within the past 2 years (e.g., with disease-modifying agents, corticosteroids, or immunosuppressants). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy.
- History of or current non-infectious pneumonitis requiring systemic corticosteroids, or a history of interstitial lung disease.
- History of significant bleeding tendency or coagulopathy; prior or current long-term anticoagulation (e.g., atrial fibrillation with CHADS₂ score ≥ 2).
- Uncontrolled comorbid conditions, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or psychiatric/social conditions that would limit compliance with study requirements or ability to provide written informed consent.
- History of myocarditis, cardiomyopathy, or malignant arrhythmias. Within 12 months prior to study treatment: unstable angina requiring hospitalization, congestive heart failure, or vascular disease (e.g., aortic aneurysm requiring surgical repair or peripheral venous thrombosis), or other cardiac damage that may affect evaluation of study-drug safety (e.g., poorly controlled arrhythmias, myocardial infarction or ischemia); within 6 months prior: esophagogastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, enteric fistula, intestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding; within 6 months prior: any arterial thromboembolic event, NCI CTCAE v5.0 grade ≥3 venous thromboembolism, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy; within 1 month prior: acute exacerbation of COPD; current hypertension with SBP ≥160 mmHg or DBP ≥100 mmHg despite oral antihypertensive therapy.
- Active or past history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or chronic diarrhea.
- Serious infection within 4 weeks before study treatment, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 10 days before study treatment (excluding antiviral therapy for hepatitis B or C).
- Major surgery or severe trauma within 30 days before study treatment; minor local surgery within 3 days before study treatment (excluding peripherally inserted central catheter placement).
- History of immunodeficiency; positive HIV antibody; or current long-term systemic corticosteroid or other immunosuppressive therapy.
- Known active tuberculosis (TB). Subjects with suspected active TB must be clinically ruled out (e.g., sputum for mycobacteria, chest imaging). Known active syphilis infection.
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Untreated active hepatitis B (HBsAg-positive with HBV-DNA > 1,000 copies/mL \[200 IU/mL] or above the assay lower limit). Subjects with hepatitis B must receive antiviral therapy during the study; active hepatitis C (HCV-antibody positive with HCV-RNA above the assay lower limit).
- Live vaccine within 30 days before study treatment or planned receipt of a live vaccine during the study.
- Known allergy to any component of the study drugs; history of severe hypersensitivity to other monoclonal antibodies.
- Known psychiatric illness, substance abuse, alcoholism, or drug dependence.
- Pregnant or breastfeeding women.
- Any prior or current disease, therapy, or laboratory abnormality that may confound study results, interfere with full participation, or not be in the subject's best interest to participate.
- Local or systemic disease not due to malignancy, or tumor-related conditions/symptoms that may confer high medical risk and/or uncertainty in survival assessment, such as leukemoid reaction due to tumor (WBC > 20 × 10⁹/L), cachexia (e.g., >10% body-weight loss within 3 months before screening), or BMI ≤ 18 (BMI = weight[kg] / height [m²]).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yikan Cheng, M.D., Ph.D. contact
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Qian Wu, +86-020-38379764, zslyllb@mail.sysu.edu.cn
About this study
Most colorectal cancers are microsatellite stable (MSS) or mismatch repair-proficient (pMMR) subtypes, which show limited efficacy to PD-1 inhibitors. Radiotherapy can enhance the release of tumor-associated antigens, thereby improving the responsiveness of pMMR/MSS colorectal cancers to PD-1 blockade. Tumor-draining lymph nodes (TDLNs) are critical sites where PD-1 inhibitors exert their antitumor effects; however, previous studies have reported that direct radiation-induced damage and fibrosis may impair lymphatic drainage and antitumor immunity. Early reports have demonstrated a remarkable pathological complete response (pCR) rate of 77.8% with lymph node-sparing short-course radiotherapy (25 Gy in 5 fractions) in locally advanced rectal cancer. In metastatic colorectal cancer, single-fraction high-dose irradiation (6-8 Gy) has been shown to induce robust abscopal effects. Based on these findings, our study aims to evaluate whether lymph node-sparing hypofractionated radiotherapy (25 Gy/5F or 24 Gy/4F) followed sequentially by chemotherapy and PD-1 blockade can increase the pCR rate, improve tolerability, and ultimately enhance outcomes in patients with pMMR/MSS high-risk locally advanced colon cancer.
- Being tested
- Node-Sparing Radiotherapy(25Gy/5F) plus Chemotherapy and PD-1 inhibitor, Node-Sparing Radiotherapy(24Gy/4F) plus Chemotherapy and PD-1 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Node-Sparing Radiotherapy(25Gy/5F) plus Chemotherapy and PD-1 inhibitorCombination product
Patients will receive node-sparing modified short-course radiotherapy(25Gy/5F), followed by 4 cycles of CAPOX chemotherapy combined with a PD-1 inhibitor. After neoadjuvant treatment, patients will undergo surgery.
Node-Sparing Radiotherapy(24Gy/4F) plus Chemotherapy and PD-1 inhibitorCombination product
Patients will receive node-sparing modified short-course radiotherapy(24Gy/4F), followed by 4 cycles of CAPOX chemotherapy combined with a PD-1 inhibitor. After neoadjuvant treatment, patients will undergo surgery.
| Study group | Role | What they receive |
|---|---|---|
| 25Gy/5F Radiotherapy Group | Experimental | Node-Sparing Short-Course RT (25Gy/5F) followed by sequential Chemotherapy and PD-1 inhibitor as total neoadjuvant therapy. Receives: Combination Product: Node-Sparing Radiotherapy(25Gy/5F) plus Chemotherapy and PD-1 inhibitor |
| 24Gy/4F Radiotherapy Group | Experimental | Node-Sparing Short-Course RT (24Gy/4F) followed by sequential Chemotherapy and PD-1 inhibitor as total neoadjuvant therapy. Receives: Combination Product: Node-Sparing Radiotherapy(24Gy/4F) plus Chemotherapy and PD-1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response(pCR) Rate
Evaluate 25Gy/5F or 24Gy/4F node-sparing modified short-course radiotherapy followed by sequential chemotherapy and PD-1 inhibitor as total neoadjuvant therapy can better improve the pathological complete response(pCR) rate in colon cancer.
Measured: From enrollment to 2-4 weeks after surgery
Secondary outcomes (7)
Tumor regression grade (TRG)
Measured: From enrollment to 2-4 weeks after surgery
Tumor downstaging rate
Measured: From enrollment to 2-4 weeks after finishing preoperative treatment
R0 resection rate
Measured: From enrollment to 2-4 weeks of surgery
3-year overall survival (OS) rate
Measured: From enrollment to 3 years after finishing Surgery
Event-Free Survival (EFS)
Measured: From enrollment to 3 years after finishing Surgery
3-year distant metastasis rate
Measured: From enrollment to 3 years after finishing Surgery
3-year local recurrence rate
Measured: From enrollment to 3 years after finishing Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start30 Aug 2025
- Primary completion29 Aug 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant TherapiesStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanxin Luo,MD, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230639
- Sponsor's protocol ID
- 2025ZSLYEC502
- Acronym
- MODIFI-CC
- Status last verified
- Dec 2025
- First submitted
- 16 Sep 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Node-Sparing Hypofractionated Radiotherapy Plus Chemotherapy and PD-1 Inhibitor in pMMR/MSS High-Risk Locally Advanced Colon Cancer: A Prospective, Randomized, Phase II Trial
- ClinicalTrials.gov ID
- NCT07230639
- Acronym / sponsor ID
- MODIFI-CC / 2025ZSLYEC502
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 29 Aug 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 17 Nov 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.
Most colorectal cancers are microsatellite stable (MSS) or mismatch repair-proficient (pMMR) subtypes, which show limited efficacy to PD-1 inhibitors. Radiotherapy can enhance the release of tumor-associated antigens, thereby improving the responsiveness of pMMR/MSS colorectal cancers to PD-1 blockade. Tumor-draining lymph nodes (TDLNs) are critical sites where PD-1 inhibitors exert their antitumor effects; however, previous studies have reported that direct radiation-induced damage and fibrosis may impair lymphatic drainage and antitumor immunity. Early reports have demonstrated a remarkable pathological complete response (pCR) rate of 77.8% with lymph node-sparing short-course radiotherapy (25 Gy in 5 fractions) in locally advanced rectal cancer. In metastatic colorectal cancer, single-fraction high-dose irradiation (6-8 Gy) has been shown to induce robust abscopal effects. Based on these findings, our study aims to evaluate whether lymph node-sparing hypofractionated radiotherapy (25 Gy/5F or 24 Gy/4F) followed sequentially by chemotherapy and PD-1 blockade can increase the pCR rate, improve tolerability, and ultimately enhance outcomes in patients with pMMR/MSS high-risk locally advanced colon cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25Gy/5F Radiotherapy Group | Experimental | Combination Product: Node-Sparing Radiotherapy(25Gy/5F) plus Chemotherapy and PD-1 inhibitorNode-Sparing Short-Course RT (25Gy/5F) followed by sequential Chemotherapy and PD-1 inhibitor as total neoadjuvant therapy. |
| 24Gy/4F Radiotherapy Group | Experimental | Combination Product: Node-Sparing Radiotherapy(24Gy/4F) plus Chemotherapy and PD-1 inhibitorNode-Sparing Short-Course RT (24Gy/4F) followed by sequential Chemotherapy and PD-1 inhibitor as total neoadjuvant therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Voluntarily signs a written informed consent form.
- Age ≥ 18 and ≤ 75 years at enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy > 2 years.
- Histologically confirmed colon adenocarcinoma (without squamous or sarcomatoid components).
Key exclusion criteria (27 listed)
- Suspicious metastatic lesions or the presence of unresectable locally advanced disease, regardless of stage.
- Malignancy other than colorectal cancer within 5 years prior to enrollment. Subjects cured by local therapy for other malignancies (e.g., basal or squamous cell skin cancer, superficial bladder cancer, ductal carcinoma in situ) are not excluded.
- Receipt of any investigational drug or device within 4 weeks prior to the first dose of study drug.
- Intestinal obstruction, perforation, gastrointestinal bleeding, or other conditions requiring emergency surgery.
- Multiple primary colorectal cancers.
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 |
|---|---|---|
| Node-Sparing Radiotherapy(25Gy/5F) plus Chemotherapy and PD-1 inhibitorPatients will receive node-sparing modified short-course radiotherapy(25Gy/5F), followed by 4 cycles of CAPOX chemotherapy combined with a PD-1 inhibitor. After neoadjuvant treatment, patients will undergo surgery. | Combination product | 25Gy/5F Radiotherapy Group |
| Node-Sparing Radiotherapy(24Gy/4F) plus Chemotherapy and PD-1 inhibitorPatients will receive node-sparing modified short-course radiotherapy(24Gy/4F), followed by 4 cycles of CAPOX chemotherapy combined with a PD-1 inhibitor. After neoadjuvant treatment, patients will undergo surgery. | Combination product | 24Gy/4F Radiotherapy Group |
Primary outcome
Pathological Complete Response(pCR) Rate
Time frame: From enrollment to 2-4 weeks after surgery
Evaluate 25Gy/5F or 24Gy/4F node-sparing modified short-course radiotherapy followed by sequential chemotherapy and PD-1 inhibitor as total neoadjuvant therapy can better improve the pathological complete response(pCR) rate in colon cancer.
7 secondary outcomes
Tumor regression grade (TRG)
Time frame: From enrollment to 2-4 weeks after surgery
Tumor downstaging rate
Time frame: From enrollment to 2-4 weeks after finishing preoperative treatment
R0 resection rate
Time frame: From enrollment to 2-4 weeks of surgery
3-year overall survival (OS) rate
Time frame: From enrollment to 3 years after finishing Surgery
Event-Free Survival (EFS)
Time frame: From enrollment to 3 years after finishing Surgery
3-year distant metastasis rate
Time frame: From enrollment to 3 years after finishing Surgery
3-year local recurrence rate
Time frame: From enrollment to 3 years after finishing 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 26 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Yikan Cheng, M.D., Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Node-Sparing Radiotherapy(25Gy/5F) plus Chemotherapy and PD-1 inhibitor and Node-Sparing Radiotherapy(24Gy/4F) plus Chemotherapy and PD-1 inhibitor in people with Neoadjuvant Therapies and Immune Checkpoint Therapy, run by Sixth Affiliated Hospital, Sun Yat-sen 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 17 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 26 Dec 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?
Contact Yanxin Luo, M.D., Ph.D. (+86-20-38254221, luoyx25@mail.sysu.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) Rate (time frame: From enrollment to 2-4 weeks after surgery). 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 26 Dec 2025.