Actively Recruiting
Node-Sparing Short-Course Radiotherapy Followed by First-Line Chemotherapy Plus Bevacizumab and PD-1 Inhibitor Versus Chemotherapy Plus Bevacizumab Alone in Metastatic pMMR/MSS Colorectal Cancer: A Randomized Phase II/III Trial (MODIFI-CRC)
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-08-07
286
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying metastatic colorectal cancer, specifically patients with proficient mismatch repair (pMMR) and microsatellite stable (MSS) tumors, who currently have limited treatment options. This phase II/III trial aims to evaluate if adding node-sparing modified short-course radiotherapy to chemotherapy, bevacizumab, and PD-1 inhibitor therapy can improve the objective response rate and progression-free survival compared to chemotherapy plus bevacizumab alone. The study also focuses on treatment tolerance and overall prognosis in these patients. Participants are assigned randomly to one of two groups. The experimental group receives node-sparing modified short-course radiotherapy followed by eight cycles of FOLFOX chemotherapy combined with bevacizumab and a PD-1 inhibitor, then maintenance therapy with bevacizumab, PD-1 inhibitor, and 5-fluorouracil every two weeks. The comparison group receives eight cycles of FOLFOX chemotherapy with bevacizumab, followed by maintenance with bevacizumab and 5-fluorouracil every two weeks. The study treatments are administered as first-line therapy. During the study, participants will have measurable lesions assessed over up to 36 months to determine objective response rate and progression-free survival. Researchers will also monitor duration of response, disease control rate, overall survival, treatment-related adverse effects, and time to response. Participants provide tumor tissue and blood samples for research, and their health status, organ function, and tumor responses will be regularly evaluated throughout the trial. The total study participation may last several years, with ongoing safety monitoring.
CONDITIONS
Brief Title
Node-Sparing Short-Course Radiotherapy Plus Chemotherapy, Bevacizumab and PD-1 Inhibitor in Metastatic pMMR/MSS Colorectal Cancer (MODIFI-CRC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signs a written informed consent form.
- Aged between 18 and 75 years at enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival longer than 3 months.
- Histologically or cytologically confirmed colorectal adenocarcinoma.
- No prior systemic anti-tumor therapy for recurrent or metastatic disease; prior neoadjuvant or adjuvant therapy allowed if recurrence/metastasis occurs 12 months or more after last dose.
- At least one measurable lesion per RECIST v1.1 (excluding brain metastases).
- Able to provide 10-20 unstained tumor tissue FFPE slides from biopsy or archival material within 3 years.
- Willing to provide tumor tissue and peripheral blood samples during screening and study.
- Adequate organ function as defined by specified hematologic, renal, hepatic, coagulation, and cardiac parameters.
- Women of childbearing potential must have negative pregnancy test and agree to use effective contraception during and after study treatment.
- Willing and able to comply with study visits, procedures, and tests.
You will not qualify if you...
- Known MSI-H or dMMR tumor status.
- History of other malignancies within past 3 years except certain treated cancers.
- Prior immunotherapy or immune cell-based therapies targeting tumor immunity.
- Prior therapies targeting EGFR or VEGF/VEGFR pathways.
- Active central nervous system metastases or related conditions.
- Symptomatic or recurrent pleural, pericardial effusion, or ascites.
- Prior systemic or local therapy for locally advanced rectal cancer.
- Recent use of nonspecific immunomodulators or anti-tumor traditional Chinese medicine.
- Active autoimmune disease requiring systemic treatment within 2 years.
- History of pneumonitis requiring corticosteroids or interstitial lung disease.
- History of bleeding disorders or coagulopathy; long-term anticoagulation.
- Uncontrolled comorbidities or psychiatric/social conditions impairing participation.
- Recent serious cardiovascular events or unstable heart conditions.
- Recent gastrointestinal complications or thromboembolic events.
- Active or prior inflammatory bowel disease.
- Recent serious infections or immunodeficiency.
- Known active tuberculosis or syphilis.
- History of organ or stem cell transplantation.
- Untreated active hepatitis B or C infection.
- Recent live vaccination.
- Known allergy or hypersensitivity to study drugs.
- Psychiatric disorders, substance abuse, or drug dependence.
- Pregnant or breastfeeding women.
- Conditions or lab abnormalities interfering with study or posing high risk.
- Significant gastrointestinal obstruction or tumor invasion posing bleeding risk or complications.
- Presence of free intraperitoneal gas not due to recent procedures.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of 8 chemotherapy cycles plus ongoing maintenance therapy every 2 weeks
Participants receive either node-sparing modified short-course radiotherapy followed by 8 cycles of FOLFOX chemotherapy combined with bevacizumab and a PD-1 inhibitor with maintenance therapy every 2 weeks, or 8 cycles of FOLFOX chemotherapy combined with bevacizumab followed by maintenance therapy every 2 weeks.
Visits every 2 weeks during maintenance therapy; chemotherapy visits as scheduled for 8 cycles
Duration - Up to 36 months
Participants are monitored for disease progression, survival, and treatment-related adverse effects following treatment completion.
Visits according to study schedule for up to 36 months
Trial Site Locations
Total: 1 location
1
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
Research Team
Y
Yanxin Luo, M.D., Ph.D.
Y
Yikan Cheng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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