Clinical trial NCT07003815: Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Biliary Tract Cancer
Advanced Cancer
Keywords: Biliary Tract Cancer
Envafolimab
Simvastatin
Immunotherapy
Chemotherapy
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective Response Rate (ORR) at 24 Weeks
timeFrame: From treatment initiation until 24 weeks (or disease progression, if earlier).
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 2 years.
measure: Overall Survival (OS)
timeFrame: Up to 2 years.
measure: Disease Control Rate (DCR)
timeFrame: Up to 2 years.
measure: Duration of Response (DOR)
timeFrame: Up to 2 years.
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose until 30 days after last dose.
Other outcomes:
Locations:
Study officials:
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