Biliary tract cancer
Conditions
Interventions
Experimental group:The combination of iparomlimab and tuvonralimab, lenvatinib, and GEMOX therapy
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patient has voluntarily agreed to participate in the study and has provided written informed consent. 2. Age between 18 and 70 years (inclusive), with no gender restrictions. 3. Histologically or cytologically confirmed potentially resectable locally advanced biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), perihilar cholangiocarcinoma (PBDT), and gallbladder cancer (GBC). 4. No prior systemic anti-cancer therapy for biliary tract tumors. 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 6. Life expectancy of at least 3 months. 7. At least one measurable target lesion, as defined by RECIST version 1.1, confirmed by imaging during the screening period. 8. Child-Pugh liver function classification A. 9. Bone marrow, liver, and kidney function were adequate, and the following laboratory test criteria were met within 7 days before treatment: a) Blood routine: absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet count >=90×10^9/L; Hemoglobin >=90g/L. b) Liver function: AST and ALT 2000 copies /mL should receive antiviral therapy according to the treatment guidelines. Patients who were receiving antiviral therapy at screening were required to ensure that HBV-DNA was less than 2000 copies per milliliter and to continue receiving antiviral therapy for the duration of the study. b) For patients with hepatitis C virus (HCV) infection: if the presence of HCV RNA was confirmed by testing, the subject was not enrolled. 10. Women of childbearing potential must agree to use highly effective methods of contraception during the study and for 120 days after the final dose of study treatment. A negative urine or serum pregnancy test must be confirmed within 7 days prior to first administration of study drug. Men who are not surgically sterile must also agree to use effective contraception during the study and for 120 days following the last dose.
Exclusion criteria
Exclusion criteria: 1. Administration of the investigational drug within 4 weeks before initiation of study treatment; 2. Previous systemic therapy for biliary tract cancer; 3. Prior treatment with gemcitabine-based chemotherapy, tyrosine kinase inhibitor (TKI), or any tumor immunotherapy (e.g., PD-1/L1 inhibitor, CTLA-4 inhibitor, etc.); 4. Known history of severe allergy to any immunosuppressant; 5. Allergy to apalorito volrelizumab or any of its excipients; Allergy to oxaliplatin or any of its excipients; Allergy to gemcitabine or any of its excipients; Allergy to lenvatinib or any of its excipients; 6. The presence of pericardial effusion, uncontrolled pleural effusion, or clinically evident ascites within 7 days before treatment was defined as meeting any of the following criteria: (a) ascites was detected by physical examination during screening; Or (b) ascites requiring puncture and drainage during screening; 7. There was no clinical evidence of esophageal or gastric varices related to portal hypertension within 6 months before the initiation of treatment; 8. The presence of any hemorrhagic or thrombotic disorder within 6 months before treatment or the use of an anticoagulant for which an international normalized ratio (INR) is monitored (e.g., warfarin or a similar drug); Patients with active malignant tumors other than bile duct malignant tumors within 9.5 years or at the same time (cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, breast cancer in situ, etc., are excluded); 10. Known central nervous system (CNS) metastases and/or leptomeningeal disease before treatment; 11. Have active autoimmune disease or a history of autoimmune disease with possible recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects controlled only with hormone replacement therapy are eligible]); Subjects with skin diseases requiring no systemic treatment such as vitiligo, psoriasis, alopecia, controlled type I diabetes treated with insulin, or asthma that had been completely resolved in childhood and without any intervention in adulthood were included. Patients with asthma who required medical intervention with bronchodilators were excluded. 12. According to the investigator's judgment, the patient had other factors that may affect the results of the study or lead to the forced termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental diseases) requiring combined treatment, serious laboratory test abnormalities, accompanied by family or social factors, which would affect the safety of the patient. 13. Pregnant or lactating women or women/men preparing to give birth; 14. Estimated insufficient compliance of the subjects to participate in the clinical trial or subjects with other factors considered by the investigators to be unsuitable for the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate (MPR rate);Objective Response Rate, ORR;Overall survival;Disease-free survival (DFS);Progression-free survival (PFS);Disease control rate (DCR);Pathological complete response rate (pCR rate); | — |
Countries
China
Contacts
Public ContactDongkai Zhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed