Colorectal cancer
Conditions
Interventions
Experimental group:GM-CSF + PD-1 antibody + radiotherapy
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Be fully informed about the study and voluntarily sign an informed consent form; 2. 18-75 years old (as of the date of signing informed consent), male or female; 3. Have a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic microsatellite stable (MSS) colorectal cancer; 4. Patients need to have at least one evaluable or measurable lesion (RECIST 1.1); when a lesion with prior local treatment (radiotherapy, ablation, vascular intervention, etc.) is the only lesion, the lesion must have a clear imaging basis for disease progression; 5. Patient has failed previous standard first-line systemic chemotherapy, with failure of standard chemotherapy defined as: disease progression during treatment or within 6 months of the last treatment; or intolerable toxic side effects during treatment: (1) Prior neoadjuvant or adjuvant chemotherapy is allowed. Neoadjuvant/adjuvant therapy is considered a failure of first-line systemic chemotherapy for progressive disease if disease progression/relapse occurs during or within 6 months of the end of neoadjuvant/adjuvant therapy; (2) Prior standard therapy did not include anti-angiogenic small molecule inhibitors or monoclonal antibodies; 6. ECOG score 0-1; 7. Expected survival >= 12 weeks; 8. Function of vital organs in accordance with the following requirements (no blood components and cell growth factors allowed within 14 days prior to enrollment): absolute neutrophil count >= 1.5 x 10^9/L; platelets >= 100 x 10^9/L; hemoglobin >= 9 g/dL; serum albumin >= 3 g/dL; bilirubin <= 1.5 x ULN; ALT and AST <= 2.5 x ULN (note: <= 5 x ULN in patients with liver metastases); serum creatinine <= 1.5 x ULN; 9. Male or female patients of childbearing potential voluntarily use an effective method of contraception, such as a double barrier method, condoms, oral or injectable contraceptive medications, or IUDs, during the study period and within 6 months of the last study dose. All female patients will be considered fertile unless the female patient is spontaneously menopausal, has undergone artificial menopause, or has undergone sterilization (e.g., hysterectomy, bilateral adnexal resection, or radiation ovarian irradiation).
Exclusion criteria
Exclusion criteria: 1. Prior treatment with anti-PD-1/L1 immune drugs or other immune experimental drugs. 2. Patients with severe autoimmune disease: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc. 3. Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia. 4. Patient with risk factors for bowel perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer or other known risk factors for bowel perforation. 5. History of other malignancies. 6. Patient with active infection, heart failure, previous heart attack within 6 months, unstable angina or unstable arrhythmia. 7. Physical examination or clinical trial findings that, in the opinion of the investigator, may interfere with the results or place the patient at increased risk of treatment complications, or other uncontrollable disease. 8. Patients who, in the opinion of the investigator, have a current lesion requiring palliative decompensated radiotherapy. 9. Women who are breastfeeding or pregnant. 10. Congenital or acquired immunodeficiency disorders including human immunodeficiency virus (HIV), or history of organ transplantation, allogeneic stem cell transplantation. 11. Known infection with hepatitis B virus (HBV), hepatitis C virus (HCV), active tuberculosis. 12. Patient has had oncology vaccination or other vaccination within 4 weeks prior to starting treatment (note: since injectable seasonal influenza vaccines are mostly inactivated vaccines and therefore allowed, intranasal preparations are usually live attenuated vaccines and therefore not allowed). 13. Patients on other immune agents, chemotherapeutic agents, other drugs in clinical studies, and cortisol therapy requiring long-term use were excluded from enrollment. 14. Patients with psychiatric disorders, substance abuse, or social problems that affect compliance will not be enrolled upon physician review. 15. Patients who are allergic to or contraindicated to the treatment drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR (Objective Response Rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progress-Free Survival;Incidence of treatment-related toxicities; | — |
Countries
China
Contacts
Public ContactLi Yongheng
Beijing Cancer Hospital
Outcome results
None listed