Malignant biliary tumor
Conditions
Interventions
Vibecotecotamab combined with Putilimab for the treatment of EGFR-positive refractory advanced biliary malignant tumors:Vibecotecotamab combined with Putilimab for the treatment of EGFR-positive refra
Sponsors
Sichuan University West China Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1 Age: 18 - 70 years old, gender not restricted; 2 Patients with untreated primary advanced biliary system malignant tumors diagnosed by pathological histology or cytology; 3 Physical condition: ECOG PS score: 0 - 1; 4 Subject evaluated by the pathological laboratory: EGFR IHC >= 1+; 5 Have undergone at least one line of systemic drug treatment; 6 According to the RECIST 1.1 standard, there is at least one measurable target lesion that can be examined by CT or MRI; 7 Laboratory test indicators meet the following requirements: (1) Bone marrow function: Hemoglobin Hb >= 90g/L; White blood cell count WBC >= lower limit of normal value; Absolute neutrophil count ANC >= 1.5×10^9/L; Platelet count >= 100×10^9/L; (2) Renal function: Cr = 55 ml/min; (3) Liver function: Total bilirubin 38?; 12 Expected good compliance, able to follow the protocol requirements for follow-up of efficacy and adverse reactions. 13 Expected survival period > 3 months.
Exclusion criteria
Exclusion criteria: 1 Had been diagnosed with other malignant tumors within the past 5 years (excluding carcinoma in situ and basal cell carcinoma) 2 Had known central nervous system metastasis (excluding those whose disease was controlled and asymptomatic 4 weeks after radiotherapy or surgery) or had evidence of cancer meningitis 3 Had mental or neurological disorders and could not cooperate 4 Had previously received ADC drugs with a loading dose of MMAE 5 Were preparing for or had previously received organ or bone marrow transplantation 6 Had any active autoimmune disease or autoimmune disease history 7 Had received live vaccines within 30 days before the first administration (injection-type seasonal influenza vaccine is allowed as it is an inactivated vaccine) 8 Had uncontrolled clinical symptoms or diseases of the heart 9 Had active infection or fever (except for definite tumor fever) 10 Had a history or evidence of interstitial lung disease or active non-infectious pneumonia 11 Had other diseases that made them unsuitable for enrollment, such as immunodeficiency, active tuberculosis, positive hepatitis B (with HBV-DNA 10mg/day prednisone for efficacy within 14 days before enrollment 14 Had received radiotherapy, chemotherapy, targeted therapy or immunotherapy within 4 weeks before enrollment 15 Were pregnant or lactating women 16 Were considered unsuitable for enrollment by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Progression Free Survival, PFS;Disease control rate, DCR;Overall survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactCao Dan
Sichuan University West China Hospital
Outcome results
None listed