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New treatment option for Colorectal Cancer
Official title Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients
ClinicalTrials.gov ID: NCT06280495
What this study is testing
What is Oxaliplatin?
Oxaliplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.
Also referred to as Eloxatin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this study is to assess whether the addition of Serplulimab (a PD-1 inhibitor) and Bevacizumab (an anti-angiogenesis agent) to the standard FOLFOX chemotherapy can enhance the immune microenvironment in the liver, increase T lymphocyte infiltration, and consequently improve the postoperative prognosis for patients with surgically resectable colorectal cancer liver metastases (RAS/BRAF wild-type, pMMR/MSS) compared to FOLFOX alone.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age ≥18 and ≤75 years old
- Histologically confirmed colorectal adenocarcinoma
- Radiological and/or pathological confirmation of liver metastases, with ≤5 lesions
- Genetic testing and/or immunohistochemistry confirmation of RAS, BRAF wild-type, and pMMR/MSS
- Absence of extrahepatic metastases confirmed by CT, MRI, or PET/CT (if necessary)
You likely can't join if
- Diagnosis of colorectal cancer with distant extrahepatic metastases
- Prior chemotherapy, targeted therapy, intervention, or immunotherapy for liver metastases
- No planned surgical resection for liver metastatic lesions
- Received oxaliplatin-containing adjuvant chemotherapy regimen within the past one year
- Any toxicity residuals from previous chemotherapy, excluding alopecia, such as peripheral neuropathy ≥NCI CTC v3.0 grade 2
- Use of immunosuppressive drugs one week prior to study treatment initiation, excluding topical corticosteroids via nasal, inhalational, or other...
See the full eligibility criteria
- Age ≥18 and ≤75 years old
- Histologically confirmed colorectal adenocarcinoma
- Radiological and/or pathological confirmation of liver metastases, with ≤5 lesions
- Genetic testing and/or immunohistochemistry confirmation of RAS, BRAF wild-type, and pMMR/MSS
- Absence of extrahepatic metastases confirmed by CT, MRI, or PET/CT (if necessary)
- Primary colorectal tumor has been or can be radically resected
- Liver metastatic lesions are resectable (including radiofrequency ablation and SBRT), and postoperative NED (no evidence of disease) is expected. Resectable liver metastases are specifically defined as ① ≤5 metastatic...
- No prior anti-tumor therapy for liver metastases, except for surgical resection of primary lesions
- Normal hematological function (platelets \>90×109/L; white blood cells \>3×109/L; neutrophils \>1.5×109/L)
- Serum bilirubin ≤1.5 times the upper limit of normal (ULN), transaminases ≤5 times ULN, alkaline phosphatase ≤2.5 ULN, no ascites, normal coagulation function, albumin ≥35g/L
- Liver function classified as Child-Pugh grade A
- Serum creatinine below the upper limit of normal (ULN), or calculated creatinine clearance rate \>50ml/min (using Cockcroft-Gault formula)
- ECOG performance status 0-1
- Expected lifespan \>3 months
- Signed written informed consent
- Willing and able to be followed up until death or end of study or study termination.
- Diagnosis of colorectal cancer with distant extrahepatic metastases
- Prior chemotherapy, targeted therapy, intervention, or immunotherapy for liver metastases
- No planned surgical resection for liver metastatic lesions
- Received oxaliplatin-containing adjuvant chemotherapy regimen within the past one year
- Any toxicity residuals from previous chemotherapy, excluding alopecia, such as peripheral neuropathy ≥NCI CTC v3.0 grade 2
- Use of immunosuppressive drugs one week prior to study treatment initiation, excluding topical corticosteroids via nasal, inhalational, or other routes or physiological doses of systemic corticosteroids (i.e., not...
- Interstitial lung disease requiring corticosteroid treatment
- Known active autoimmune disease requiring symptomatic treatment or with a history of such disease within the past 2 years. Patients with vitiligo, psoriasis, alopecia, or Graves' disease who have not required systemic...
- Known history of primary immunodeficiency
- Patients with active tuberculosis
- History of allogeneic organ or hematopoietic stem cell transplantation
- Known allergy to any monoclonal antibody or chemotherapy drug (Fluorouracil, oxaliplatin) preparation or excipient component
- Bleeding tendency or coagulation disorder
- Significant symptoms of intestinal obstruction
- Hypertensive crisis or hypertensive encephalopathy
- Severe uncontrolled systemic complications such as infection or diabetes
- Clinically severe cardiovascular diseases such as cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), hypertension that remains uncontrolled after...
- Past or physical examination showing central nervous system diseases (such as primary brain tumor, epilepsy uncontrolled by standard treatment, any history of brain metastasis, or stroke)
- Diagnosis of other malignant tumors within the past 5 years (excluding basal cell carcinoma and/or carcinoma in situ of the cervix after radical surgery)
- Patients who received any investigational drug therapy within the last 28 days prior to the study
- Pregnant or lactating women and women of childbearing age not using or refusing to use effective non-hormonal contraception (intrauterine devices, barrier contraception combined with spermicidal gel, or sterilization...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.