Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer

Launched by TONGJI HOSPITAL · May 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for advanced biliary tract cancer, which is a type of cancer affecting the bile ducts and gallbladder. The researchers want to see if combining an immunotherapy drug called Envafolimab with standard chemotherapy (gemcitabine and cisplatin) and a cholesterol-lowering medication called simvastatin can help shrink tumors or slow down the cancer's growth. They are also looking at how safe this combination is for patients.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of advanced biliary tract cancer that cannot be surgically removed. Participants will receive the treatment every three weeks for about six months and will have regular check-ups, including scans and blood tests, to monitor their progress and any side effects. This trial is not currently recruiting, but it aims to help find more effective treatment options for patients facing this challenging disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age : ≥18 years old.
• • Diagnosis : Histologically confirmed unresectable, locally advanced, or metastatic biliary tract adenocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer).
• • Prior Treatment :Treatment-naïve for unresectable/metastatic disease at initial diagnosis, OR Disease recurrence ≥6 months after curative surgery or adjuvant therapy.
• • Performance Status : ECOG PS 0 or 1.
• • Measurable Disease : At least one radiologically measurable lesion per RECIST 1.1 (tumor lesion ≥10 mm on CT scan, lymph node ≥15 mm in short axis).
• • Organ Function : No severe functional impairment of heart, lung, brain, or other vital organs.
• Exclusion Criteria:
• • Disease Type : Ampulla of Vater cancer.
• • Autoimmune Disease : Active or previously documented autoimmune/inflammatory disorders.
• • Allergy : Hypersensitivity to any study drug (Envafolimab, gemcitabine, cisplatin, or simvastatin).
• • Liver Function : Decompensated liver dysfunction.
• • Psychiatric History : Severe psychiatric disorders.
• • Recent Trials : Participation in other drug/device trials within 4 weeks prior to enrollment.
• • Compliance : Inability to adhere to protocol requirements or follow-up schedule.
• • Investigator's Discretion : Any other condition deemed unsuitable for participation by the investigator.