Actively Recruiting
Phase II Trial of Short-Course Radiotherapy, CAPEOX Chemotherapy, and Serplulimab in MSS/pMMR Rectal Cancer with Synchronous Oligometastases
Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-03-25
51
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Zhejiang University
Lead Sponsor
N
Ningbo No.2 Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Colorectal cancer is a common and deadly disease, with many patients diagnosed when cancer has spread to other sites, especially the liver. This study focuses on patients with a limited number of metastatic lesions in rectal cancer who are microsatellite stable or have proficient mismatch repair. Researchers aim to evaluate a new treatment approach combining immunotherapy-based total neoadjuvant therapy (iTNT) with short-course radiotherapy (SCRT) to improve outcomes in this challenging group. Participants in this trial will receive an experimental treatment involving short-course radiotherapy followed by four cycles of CAPEOX chemotherapy combined with Serplulimab as neoadjuvant therapy. After this, patients will undergo surgery to remove the primary tumor and receive local treatment for metastases. Following surgery, they will receive an additional four cycles of CAPEOX chemotherapy plus Serplulimab as adjuvant therapy. This treatment sequence is designed to enhance complete response rates and reduce recurrence risks. Throughout the study, patients will be monitored for progression-free survival over three years as the primary outcome. Secondary outcomes include the rate of no evidence of disease within three months after surgery, pathological complete response of the primary tumor, local recurrence rates over three years, and overall survival over five years. Participants will undergo imaging evaluations, laboratory tests, and clinical assessments to track treatment effects and safety over the study period, which runs until December 2032.
CONDITIONS
Brief Title
SCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With Oligometastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study visits and procedures
- Age between 18 and 75 years
- Histologically confirmed primary rectal adenocarcinoma within 10cm of the anal verge by MRI
- Synchronous oligometastatic rectal cancer with 2 or fewer metastatic sites and 5 or fewer total metastatic lesions confirmed by imaging
- Microsatellite stable (MSS) or proficient mismatch repair (pMMR) status confirmed by standard testing
- At least one measurable tumor lesion per RECIST v1.1
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ and bone marrow function as defined by laboratory criteria
- Use of effective contraception during treatment and for 6 months after
- Women must be post-menopausal or have a negative pregnancy test
You will not qualify if you...
- More than 2 metastatic sites or more than 5 total metastatic lesions
- Prior anti-tumor therapy for this cancer including surgery, radiotherapy, chemotherapy, targeted or immunotherapy
- Previous treatment with immune checkpoint inhibitors or adoptive cell immunotherapy
- Participation in another clinical trial except observational or survival follow-up phases
- Recent investigational drug use within 4 weeks before study drug
- Recent blood transfusion or growth factor use within 14 days before screening
- Use of immunosuppressive medications within 4 weeks before study drug except certain low-dose corticosteroids or local steroids
- Recent live or attenuated vaccines within 4 weeks before study drug
- Major surgery within 4 weeks before study drug or unhealed wounds
- Active or recent autoimmune disease within 2 years with some exceptions
- Primary immunodeficiency
- Active tuberculosis or recent treatment
- History of organ or stem cell transplantation
- Known allergies to study drugs
- Significant fluid accumulation requiring intervention
- HIV infection
- Active hepatitis B or C infection
- Active syphilis requiring treatment
- Severe recent infections
- Heart failure, arrhythmia, or significant cardiac conditions
- Uncontrolled hypertension or bleeding disorders
- Recent thromboembolic events
- High risk of gastrointestinal bleeding or recent severe bleeding
- History of serious thromboembolism
- Uncontrolled metabolic or other serious medical conditions
- Severe liver disease or cirrhosis
- Bowel obstruction or severe gastrointestinal conditions
- Interstitial lung disease or severe lung dysfunction
- Significant malnutrition unless corrected
- Other recent or active cancers except certain treated conditions
- Conditions that increase study risks or interfere with participation
- Substance abuse impacting treatment or safety
- Pregnancy or breastfeeding
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.
Duration - 1 week
Participants receive neoadjuvant short-course radiotherapy (SCRT) consisting of a total dose of 25 Gy delivered in 5 fractions of 5 Gy each.
5 visits (in-person)
Duration - Approximately 12 weeks
Participants receive 4 cycles of CAPEOX chemotherapy combined with Serplulimab as neoadjuvant therapy.
4 visits every 3 weeks (in-person)
Duration - Up to 1 week
Participants undergo total mesorectal excision (TME) of the primary tumor and local therapeutic intervention for metastatic lesions.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants receive 4 additional cycles of CAPEOX chemotherapy plus Serplulimab as adjuvant therapy following surgery.
4 visits every 3 weeks (in-person)
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
F
Feng Ye
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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