Actively Recruiting
A Phase II, Prospective, Randomized Study of Serplulimab With Second-Line Chemotherapy and Targeted Therapy Versus Chemotherapy and Targeted Therapy Alone for Early Relapse Colorectal Cancer After Adjuvant Chemotherapy
Led by Fudan University · Updated on 2026-05-22
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients with colorectal cancer who experience early relapse within one year after completing adjuvant chemotherapy with XELOX or FOLFOX. These patients have a poor prognosis, limited treatment options, and most have tumors resistant to immune checkpoint inhibitor monotherapy. This phase II randomized trial aims to assess the safety and effectiveness of adding serplulimab, a PD-1 inhibitor, to second-line chemotherapy plus targeted therapy in this high-risk group. Participants will be randomly assigned to one of two groups: the experimental arm receiving serplulimab combined with FOLFIRI chemotherapy and targeted therapy, or the control arm receiving FOLFIRI plus targeted therapy alone. Treatment regimens vary based on tumor location and RAS mutation status, with cetuximab used for left-sided, RAS wild-type tumors and bevacizumab for right-sided, RAS mutant tumors. Serplulimab is administered intravenously every two weeks at 3 mg/kg. The study uses a Pick-the-Winner design to enroll 40 patients total. During the study, researchers will monitor progression-free survival over 12 months as the primary outcome. Secondary outcomes include objective response rate, disease control rate, overall survival over 36 months, and safety assessments using standard criteria. Exploratory analyses will examine tumor and blood biomarkers to identify predictors of response and resistance. Participants will undergo scheduled visits, treatments, laboratory tests, and assessments throughout the study period to evaluate these outcomes.
CONDITIONS
Brief Title
A Phase II Randomized Trial of Serplulimab With Second-Line Chemo/Targeted Therapy for Early Relapse Colorectal Cancer After Adjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Histologically confirmed early relapse of colorectal cancer within 1 year after surgery (UICC stage IV)
- Received standard postoperative adjuvant chemotherapy (XELOX or FOLFOX)
- Tumor tissue tested as pMMR, MSS, or MSI-L
- At least one measurable tumor lesion per RECIST 1.1
- ECOG performance status 0-1
- Life expectancy of at least 3 months
- Adequate organ function including blood counts and liver, kidney, and thyroid function
- Female patients of childbearing potential must have negative pregnancy test and agree to contraception; fertile males and females at risk must use contraception during and 12 months after treatment
- Signed informed consent
- Willing and able to comply with study visits and procedures
You will not qualify if you...
- Other intestinal tumors such as gastrointestinal stromal tumors
- RAS mutation status not tested or tumor tissue showing dMMR or MSI-H
- Metastatic lesions resectable or patient plans metastasectomy
- Uncontrolled bleeding or intestinal obstruction
- Contraindications to immune checkpoint inhibitors or hypersensitivity to study drugs
- Prior or concurrent malignancy except certain treated cancers
- Active autoimmune diseases requiring treatment, except some stable conditions
- History of immunodeficiency, HIV positivity, or organ/bone marrow transplantation
- History of interstitial lung disease or recent active pulmonary tuberculosis
- Active hepatitis B or C infection above specified levels
- Severe cardiac, pulmonary, renal, or hepatic dysfunction
- Uncontrolled hypertension
- History of substance abuse
- Other factors affecting safety or compliance as judged by the investigator
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 - Up to 12 months
Participants receive Serplulimab combined with second-line chemotherapy and targeted therapy, or chemotherapy and targeted therapy alone, depending on their assigned group.
Treatment infusions every 1 to 2 weeks as per regimen
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
Q
Qingguo Li, M.D.
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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