Colorectal cancer
Conditions
Interventions
Experimental group:Injection of epaluzimab (QL1706), bevacizumab, oxaliplatin/irinotecan/fluorouracil/leucovorin intravenous infusion, and oral capecitabine treatment
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years (inclusive) at the time of ICF signing, male or female; 2. Patients with unresectable MSS/pMMR metastatic colorectal adenocarcinoma with a known BRAF V600E mutation, confirmed by histopathological examination; 3. Expected survival >= 12 weeks; 4. No prior systemic anti-tumor therapy for metastatic colorectal adenocarcinoma (if the patient previously received XELOX chemotherapy while awaiting genetic testing results, they may be enrolled if assessed by the investigator as meeting other inclusion criteria); 5. For subjects who have previously received neoadjuvant/adjuvant therapy, the period from last treatment to relapse or progression must exceed 6 months; 6. Treatment-related adverse events (AEs) have recovered to = Grade 1 according to the National Cancer Institute Common Adverse Event Terminology (NCI-CTCAE) (excluding alopecia); 7. According to RECIST 1.1 The standard requires at least one measurable lesion as assessed by the researcher. A measurable lesion should be one that has not received local treatment such as radiotherapy (lesions located within previously radiotherapy areas can also be considered measurable lesions if progression is confirmed); 8. Routine blood tests: No blood transfusions or blood products used within the past 14 days. White blood cell count >3000/µl, absolute neutrophil count (ANC) >=1500 cells/µl, platelet count >=75,000/µl, hemoglobin =9.0 g/dL, left ventricular ejection fraction (LVEF) >=50%, Fridricia-corrected QT interval (QTcF) 200 IU/mL, then levels below the detection limit are acceptable for enrollment); 12. Hepatitis C virus (HCV) antibody negative; if HCV antibody (+), then HCV-RNA testing must be negative for enrollment. Subjects with co-infection with hepatitis B and hepatitis C must be excluded (positive HBsAg or HBcAb test and positive HCV antibody test); 13. Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose. Female subjects of childbearing potential, and male subjects whose partners are women of childbearing age, must use at least one medically approved contraceptive method (such as intrauterine device, birth control pill, or condom) during the study treatment period, and for at least 3 months after the last use of ipalolitoporvorellimab (QL1706) or bevacizumab, and for at least 6 months after the last use of chemotherapy (whichever occurs later); 14. Provide a signed ICF and agree to comply with all study procedures and rules specified in the protocol; 15. Good adherence and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with other active malignancies within 5 years prior to the first use of the study drug. 1. Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, are eligible for enrollment; 2. Presence of central nervous system (CNS) or leptomeningeal metastases; 3. Received radiotherapy within 6 months prior to the start of study treatment; exceptions are made for palliative radiotherapy for bone diseases received more than 14 days prior to the start of study treatment; radiotherapy covering more than 30% of the bone marrow area is not permitted within 28 days prior to the first dose; 4. Previous treatment with targeted therapies targeting EGFR or VEGF/vascular endothelial growth factor receptor (VEGFR) (including bevacizumab, cetuximab, panitumumab, aflibercept, regorafenib, or biosimilars of the above drugs); 5. Previous treatment with any T-cell co-stimulation or immune checkpoint inhibitor therapy, including but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, etc. 6. Known history of severe allergy to any investigational drug analogue or investigational drug excipient; 7. Pleural effusion, pericardial effusion, or ascites that cannot be controlled by appropriate intervention; 8. Experiencing a cerebrovascular accident, myocardial infarction, unstable angina, or poorly controlled arrhythmia (including QTc interval >= 450 ms for men and >= 470 ms for women) within the past six months (QTc interval calculated using the Fridericia formula); 9. Heart failure according to the New York Heart Association (NYHA) criteria, class III or IV, or echocardiography showing a left ventricular ejection fraction (LVEF) 10 mg/day prednisone or an equivalent dose of the same drug) or other immunosuppressants for >7 days within 14 days prior to the first administration of the study drug or during the study period. In the absence of active autoimmune disease, inhaled or topical steroids, or adrenal hormone replacement at a dose 2) occurring within 4 week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Total Survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactYanqiao Zhang
Harbin Medical University Cancer Hospital
Outcome results
None listed