Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer

NCT ID: NCT07003815

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2028-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Envafolimab + Gemcitabine + Cisplatin + Simvastatin

Intervention Type: 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).

Interventions

Envafolimab + Gemcitabine + Cisplatin + Simvastatin

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).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wan-Guang Zhang

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Wanguang Prof. Zhang, M.D.

Role: CONTACT

wgzhang@tjh.tjmu.edu.cn

+8613636076910

Other Identifiers

TJ-IRB202401114

Identifier Type: -

Identifier Source: org_study_id