Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer

NCT07003815 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: TJ-IRB202401114
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Biliary Tract Cancer; Advanced Cancer

Keywords

Biliary Tract Cancer; Envafolimab; Simvastatin; Immunotherapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) at 24 Weeks

  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.

  From treatment initiation until 24 weeks (or disease progression, if earlier).

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  Up to 2 years.

• Overall Survival (OS)

  Up to 2 years.

• Disease Control Rate (DCR)

  Up to 2 years.

• Duration of Response (DOR)

  Up to 2 years.

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  From first dose until 30 days after last dose.

Study Arms (1)

Envafolimab + Gemcitabine/Cisplatin + Simvastatin Combination Therapy

EXPERIMENTAL

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.

Drug: Envafolimab + Gemcitabine + Cisplatin + Simvastatin

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).

Envafolimab + Gemcitabine/Cisplatin + Simvastatin Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

envafolimab; Gemcitabine; Cisplatin; Simvastatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Wanguang Prof. Zhang, M.D.

CONTACT

+8613636076910; wgzhang@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 4, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 4, 2025

Record last verified: 2025-05