The sequential treatment strategy of ERCP-RFA combined with envafolimab and surufatinib proposed in this study aims to maximally inhibit the progression of unresectable biliary tract tumors through the combined application of multiple therapeutic modalities. ERCP-RFA, as a local treatment, first reduces the tumor burden and alleviates biliary obstruction through physical ablation. Subsequently, Envafolimab enables the body to more effectively identify and attack the remaining tumor cells by activating the immune system. Finally, Surufatinib as a targeted drug, further controls the growth and spread of tumors by inhibiting tumor angiogenesis and cell proliferation. The potential advantage of this combined treatment lies in the complementary effects of different therapeutic modalities.
Sign written informed consent.;
18-79 years of age (at the time of signing the informed consent);
Patients with confirmed diagnosis of biliary tract tumors by histopathologic examination;
Patients have received no previous local treatment or any systemic treatment, and have been considered unsuitable for radical therapies
History of other malignancies (except basal cell carcinoma of the skin and/or carcinoma in situ of the cervix after radical surgery).
Previous treatment with other immune checkpoints; the subject known to have a prior allergy to macromolecular protein preparations;
Presence of any active autoimmune disease or history of autoimmune disease in the subject;
Subjects who are on immunosuppressive, or systemic, or absorbable topical hormone therapy for immunosuppression (dose >10mg/day prednisone or other equipotent hormone) and who continue to be on it within 2 weeks prior to enrollment.
Single group
Envafolimab and Surufatinib
DrugEnvafolimab: 150mg, SC, qw Surufatinib: 150mg, p.o., qd
Overall Survival
Defined as the time from the start of study treatment to death due to any cause
Disease Control Rate
Complete response(CR)and partial response(PR)
Progression-Free Survival
Assessed by the investigator using RECIST v1.1, defined as the time from the start of study treatment to disease progression, or relapse after resection of liver metastases, or death due to any cause.
Overall Response Rate
Partial response (PR) plus complete response (CR)): assessed by the investigator using RECIST v1.1 criteria
Adverse events was evaluated during received protocol therapy according to the NCI Common Terminology Criteria for NCI- CTCAE 5.0.
safety
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
