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NCT Number: NCT07003815

Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer

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.

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Key information

Conditions

Biliary Tract Cancer Advanced Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Objective Response Rate (ORR) at 24 Weeks

    Time frame: 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 outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Up to 2 years.

    Time from treatment start to disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.

  2. Overall Survival (OS)

    Time frame: Up to 2 years.

    Time from treatment start to death from any cause.

  3. Disease Control Rate (DCR)

    Time frame: Up to 2 years.

    Proportion of participants with CR, PR, or stable disease (SD) lasting ≥12 weeks.

  4. Duration of Response (DOR)

    Time frame: Up to 2 years.

    Time from first documented response (CR/PR) to disease progression or death.

  5. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From first dose until 30 days after last dose.

    Frequency and severity of adverse events graded by CTCAE v5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Wanguang Prof. Zhang, M.D.

CONTACT

[email protected]

+8613636076910

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

A Single-Arm, Exploratory Clinical Study of Envafolimab Combined With Gemcitabine, Cisplatin, and Simvastatin for the Treatment of Locally Advanced or Metastatic BTC Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jun 4, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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