Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer

Sponsor
Tongji Hospital
Study ID
NCT07003815
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Cancer
  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Envafolimab + Gemcitabine + Cisplatin + Simvastatin — DRUG
    Envafolimab (generic name): Dose: 300 mg, intravenous (IV) infusion. Schedule: Day 1 of each 21-day cycle (induction phase); every 28 days (maintenance phase). Role: PD-L1 inhibitor immunotherapy. Gemcitabine (generic name): Dose: 1,000 mg/m², IV infusion. Schedule: Days 1 and 8 of each 21-day cycle (induction phase only). Cisplatin (generic name): Dose: 25 mg/m², IV infusion. Schedule: Days 1 and 8 of each 21-day cycle (induction phase only). Simvastatin (generic name): Dose: 40 mg, oral tablet. Schedule: Daily (continuously through induction and maintenance phases). Investigational Role: Potential immunomodulator and chemosensitizer in biliary tract cancer. Treatment Phases: Induction Phase (Cycles 1-8, 21-day cycles): All four drugs administered. Maintenance Phase (Post-Cycle 8): Envafolimab + Simvastatin only (28-day cycles).

Study Details

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.

Key Dates

First listed
Jun 4, 2025
Start date
Jun 30, 2025
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2028

Study Design

Enrollment
62 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Envafolimab + Gemcitabine/Cisplatin + Simvastatin Combination Therapy
    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 Measure

Objective Response Rate (ORR) at 24 Weeks [ Time Frame: From treatment initiation until 24 weeks (or disease progression, if earlier). ]

Central Contacts

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