Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer

Tongji Hospital

Status and phase: Not yet enrolling; Phase 2

Conditions: Advanced Cancer; Biliary Tract Cancer

Treatments: Drug: Envafolimab + Gemcitabine + Cisplatin + Simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT07003815

TJ-IRB202401114

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Envafolimab + Gemcitabine/Cisplatin + Simvastatin Combination Therapy

Experimental group

Description:

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.

Treatment:

Drug: Envafolimab + Gemcitabine + Cisplatin + Simvastatin