Biliary Tract Malignancies
Conditions
Interventions
Neoadjuvant Therapy Group:Gemcitabine-Cisplatin Plus Envafolimab as Neoadjuvant Therapy
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary participation and signed informed consent;If a subject is unable to read and sign the informed consent form due to lack of capacity or other reasons, their guardian must act on their behalf for the informed consent process and sign the informed consent form. If a subject is unable to read the informed consent form (e.g., illiterate subjects), a witness must witness the informed consent process and sign the informed consent form; 2.Either gender, aged 18 to 80 years; 3.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1; 4.Histologically confirmed biliary tract malignancy; 5.Key organ function requirements must be met as follows: (1). Neutrophils >=1.5×10^9/L; platelets >=90×10^9/L; hemoglobin >=9 g/dL; (2). Coagulation: international normalized ratio (INR) =3.5 g/dL; total bilirubin 200 U/mL; (2). Tumor diameter >=5 cm or multiple tumor nodules on imaging; (3). Regional lymph node metastasis with short-axis diameter >=1.0 cm on imaging; d. Vascular invasion (portal vein or hepatic artery) on imaging; (4). Poorly differentiated or undifferentiated histologic grade. 7.Participants have at least 1 measurable lesion per RECIST v1.1 criteria; 8.Fresh fecal samples and tissue samples are available.
Exclusion criteria
Exclusion criteria: 1.Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma, or other malignant components other than cholangiocarcinoma; 2.Prior systemic therapy for biliary tract cancer (BTC), including immunotherapy, targeted therapy, or chemotherapy; 3.History of other prior or concurrent malignancies, except those with complete treatment and disease-free survival for more than 5 years; 4.Presence of active, known or suspected autoimmune disease, or requirement for long-term systemic corticosteroid therapy (equivalent to >10 mg prednisone daily) or other immunosuppressive agents. Participants using inhaled or topical corticosteroids are not excluded; 5.Presence of ascites, hepatic encephalopathy, sclerosing cholangitis, or other concurrent organ dysfunction that would preclude tolerance of general anesthesia or hepatectomy; 6.Women who are breastfeeding or pregnant; 7.Any other factors that, in the investigator’s judgment, may compromise participant safety or trial compliance, including serious comorbidities requiring ongoing treatment, clinically significant laboratory abnormalities, or relevant social or family-related issues.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response, MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Pathologic Response Rate (PCR);The specific percentage of residual viable tumor cells in postoperative resection specimens as determined by pathological examination;Objective Response Rate (ORR);Biomarker Evaluation;Disease-free survival (DFS);R0 resection rate;Adverse events; | — |
Countries
China
Contacts
Public ContactLiang Yuelong
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed