Metastatic Colorectal Cancer
Conditions
Interventions
Intervention group:Fecal Microbiota Capsules
Control Group:Placebo
Sponsors
The Eighth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Histologically/Cytologically Confirmed pMMR/MSS CRC: 2. Pathologically confirmed colorectal adenocarcinoma with proficient mismatch repair (pMMR) or microsatellite stable (MSS) status,Prior Therapy Requirements: Disease progression or intolerable toxicity during or within 3 months after completing =2 prior chemotherapy regimens containing: Fluoropyrimidine (e.g., 5-FU/capecitabine), Oxaliplatin, Irinotecan, Previous anti-cancer therapies including: EGFR inhibitors (cetuximab/panitumumab), VEGF(R) inhibitors (bevacizumab/regorafenib/ramucirumab/apatinib/other TKIs) are permitted; 3. Age & Gender: >=18 years old, both sexes eligible 4. Measurable Disease:=1 measurable lesion per RECIST v1.1,Baseline imaging performed within 21 days prior to enrollment 5. Performance Status:ECOG score 0-2 at screening 6. Hematological Requirements (within 7 days prior to treatment):Hemoglobin >=9 g/dL,WBC >=3.0×10?/L,ANC >=1.5×10?/L,Platelets >=100×10?/L 7. Organ Function (within 14 days prior to treatment):Hepatic:Total bilirubin =3 months; 9. Toxicity Recovery:Resolution of all prior treatment-related toxicities to:Grade 0-1 per NCI CTCAE v5.0 OR; 10. Meeting study inclusion criteria levels,Exceptions: Non-safety concerns (e.g., alopecia) Informed Consent:Willing/able to provide written informed consent,Cognitive capacity to comply with study procedures.
Exclusion criteria
Exclusion criteria: 1. Concurrent Clinical Trials:Participation in another interventional clinical trial within 4 weeks prior to enrollment.; 2. Secondary Malignancy:History of another primary malignancy within 3 years, except: Adequately treated basal cell carcinoma of the skin,Carcinoma in situ of the cervix; 3. Cardiovascular Disease:Clinically significant cardiovascular conditions, including:Heart failure (NYHA Class III-IV),Uncontrolled coronary artery disease, cardiomyopathy, or arrhythmia:QTcF > 450 ms (men) / > 470 ms (women) (Fridericia correction), Myocardial infarction within 6 months,Uncontrolled hypertension (=160/100 mmHg despite medication),Cerebrovascular accident (including TIA or symptomatic pulmonary embolism); 4. Neurological/Psychiatric Disorders:Functional impairment due to active CNS metastases, dementia, or severe psychiatric illness; 5. Active Infections:Fever >38.5°C (unexplained) at screeningActive tuberculosis (within 14 days),Severe infections requiring IV antibiotics/antivirals; 6. Viral Infections:HIV/AIDS (CD4+ =500 IU/mL) or HCV (RNA detectable),HBV/HCV coinfection 7. Autoimmune Disease:History of autoimmune disorders (e.g., hepatitis, pneumonitis, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism), Exceptions: Vitiligo, Childhood asthma in complete remission,Excluded: Asthma requiring chronic steroids; 8. Hypersensitivity:Known allergy to study drug/excipients; 9. GI Absorption Issues:Conditions affecting oral drug absorption (e.g., dysphagia, chronic diarrhea, bowel obstruction) 10. Prior Immunotherapy:Previous treatment with anti-PD-1/PD-L1, anti-CTLA-4, or other immune checkpoint inhibitors; 11. Immunosuppressive Therapy:Chronic immunosuppressants (e.g., corticosteroids >10 mg/day prednisone equivalent) within 4 weeks; 12. Recent Vaccination:Live/attenuated vaccines (e.g., flu, varicella) within 4 weeks; 13. Pregnancy/Breastfeeding:Positive pregnancy test or lactation in women of childbearing potential (WOCBP); 14. Surgical/Bleeding Risks:Major surgery within 30 days,Active bleeding, ulcers, or perforation; 15. Tumors encasing major blood vessels (e.g., carotid artery),Transplant History: Prior solid organ or allogeneic hematopoietic stem cell transplantation; 16. Other High-Risk Conditions:Any condition that may increase study risk or interfere with results per investigator judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survial; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;safety; | — |
Countries
China
Contacts
Public ContactYongshun Chen
The Eighth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed