Refractory MSS-type advanced colorectal cancer
Conditions
Interventions
Treatment group:None
Sponsors
Quzhou People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily participates in the study, signs the informed consent form, and has good compliance; 2. Age 18–75 years (inclusive), any gender; 3. Histologically confirmed mCRC; 4. Performance status (ECOG score) PS 0–2; 5. MSS status; 6. Received >=2 lines of standard treatment (fluoropyrimidine, oxaliplatin, irinotecan); 7. No prior use of immune checkpoint inhibitors; 8. At least one measurable lesion (RECIST 1.1); 9. Expected survival >=3 months; 10. Agree to provide tissue samples (for PD-L1 expression testing, and pathologic grading if further confirmation is needed); 11. Adequate organ function (based on clinical trial center normal values): 1) Absolute neutrophil count (ANC) >= 2×10^9/L, platelets >=100×10^9/L, hemoglobin >=90 g/L, total bilirubin (TBiL) =50 ml/min); 4) Coagulation: INR <=1.5×ULN, PT and APTT <=1.5×ULN; 12. Women of childbearing potential must have a negative serum pregnancy test within 14 days before treatment; qualified patients of reproductive potential (male and female) must agree to use reliable contraception (hormonal, barrier method, or abstinence) with their partner during the study and for at least 6 months after the last dose; 13. Have sufficient cognitive and reading ability, voluntarily sign the informed consent form, and be able to comply with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who participate in other clinical trials within 4 weeks after enrollment. 2. Patients who have had a second type of cancer within 3 years before enrollment, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix. 3. Clinically significant cardiovascular diseases such as heart failure (NYHA III-IV), controlled coronary heart disease, cardiomyopathy or arrhythmia (including male QTcF > 450 ms and female QTcF > 470 ms, QTcF interval calculated using Fridericia's formula), myocardial infarction within 6 months, poorly controlled hypertension, or cerebrovascular accidents (including transient ischemic attacks or symptomatic pulmonary embolism). 4. Neurological or psychiatric disorders affecting cognitive function. 5. Active severe infection or any unexplained fever > 38.5°C observed during the screening period, including active tuberculosis within 14 days before enrollment. 6. Infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA = 500 IU/mL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the detection limit), or co-infection with hepatitis B and C. 7. Autoimmune disease or any history of active autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction; adult subjects with vitiligo or children’s asthma in complete remission can be enrolled if no interventions are required; subjects with asthma requiring treatment for bronchiectasis cannot be enrolled). 8. Known allergy to the study drug or its excipients. 9. Multiple factors affecting oral drug absorption (e.g., difficulty swallowing, chronic diarrhea, and intestinal obstruction). 10. Previous use of anti-PD-1/PD-L1 or anti-CTLA-4 antibodies or any other antibodies targeting T-cell co-stimulatory or checkpoint pathways. 11. Conditions requiring long-term use of immunosuppressive drugs or systemic or local corticosteroids at immunosuppressive doses, or excessive glucocorticoid treatment within 4 weeks before enrollment. 12. Vaccination with any anti-infective vaccine, such as influenza or varicella vaccines, within 4 weeks before enrollment. 13. Tumors close to the internal carotid artery or other large vessels, with a risk of major bleeding, active bleeding, ulcers, or colon perforation within 30 days. 14. History of organ transplantation or allogeneic hematopoietic stem cell transplantation. 15. Other severe physical or mental diseases or laboratory abnormalities that may increase the risk of participating in this study or interfere with the study results, or subjects deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Duration of Response (DoR);Disease Control Rate (DCR);Treatment-Related Adverse Reactions (TRARs);Quality of Life Score (QoL Score); | — |
Countries
China
Contacts
Public ContactYilin Chen
Quzhou People's Hospital
Outcome results
None listed