Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer

Phase 2

Not yet recruiting

• Conditions: Biliary Tract Cancer; Advanced Cancer
• Interventions: Drug: Envafolimab + Gemcitabine + Cisplatin + Simvastatin

• Registration Number: NCT07003815
• Lead Sponsor: Tongji Hospital

Brief Summary

Brief Summary

The goal of this clinical trial is to test whether the combination of Envafolimab (an immunotherapy drug), chemotherapy (gemcitabine + cisplatin), and simvastatin can help treat advanced biliary tract cancer (BTC) that cannot be removed by surgery or has spread. The study will also evaluate the safety of this treatment combination.

Key Questions Does the combination treatment help shrink tumors or slow cancer growth better than standard options? What side effects do participants experience with this treatment?

What Will Participants Do? Receive Envafolimab (IV infusion) + gemcitabine/cisplatin (chemotherapy) + simvastatin (oral pill) every 3 weeks for up to 8 cycles (\~6 months).

After 8 cycles, continue with Envafolimab + simvastatin alone every 4 weeks until cancer worsens or side effects become too severe.

Undergo regular scans, blood tests, and clinic visits to monitor tumor response and safety.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-27
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study Start: 2025-06
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2026-12
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Envafolimab + Gemcitabine/Cisplatin + Simvastatin Combination Therapy	Envafolimab + Gemcitabine + Cisplatin + Simvastatin	Intervention(s): All enrolled participants will receive the following combination therapy: Envafolimab (300 mg, intravenous infusion, Day 1 of each 21-day cycle) - a PD-L1 inhibitor immunotherapy. Gemcitabine (1,000 mg/m², IV, Days 1 and 8 of each cycle) + Cisplatin (25 mg/m², IV, Days 1 and 8 of each cycle) - standard chemotherapy regimen. Simvastatin (40 mg, oral daily) - repurposed as a potential synergistic agent. Treatment Schedule: Initial Phase (Cycles 1-8): 21-day cycles for up to 8 cycles (≈6 months). Drugs administered as above. Maintenance Phase (Post-Cycle 8): Continue Envafolimab (300 mg, IV, every 28 days) + Simvastatin (40 mg, oral daily) until disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) at 24 Weeks	From treatment initiation until 24 weeks (or disease progression, if earlier).	Proportion of participants achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria, assessed by CT/MRI scans after 24 weeks of treatment. CR: disappearance of all target lesions; PR: ≥30% decrease in target lesion diameters.

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR)	Up to 2 years.	Time from first documented response (CR/PR) to disease progression or death.
Incidence of Treatment-Emergent Adverse Events (TEAEs)	From first dose until 30 days after last dose.	Frequency and severity of adverse events graded by CTCAE v5.0.
Progression-Free Survival (PFS)	Up to 2 years.	Time from treatment start to disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.
Overall Survival (OS)	Up to 2 years.	Time from treatment start to death from any cause.
Disease Control Rate (DCR)	Up to 2 years.	Proportion of participants with CR, PR, or stable disease (SD) lasting ≥12 weeks.