Endoscopic Retrograde Cholangiopancreatography With Radiofrequency Ablation (ERCP-RFA) Combined With Envafolimab and Surufatinib Sequential Therapy for Unresectable Biliary Tract Carcinoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-79
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Envafolimab and Surufatinib

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations