Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Envafolimab + Gemcitabine + Cisplatin + Simvastatin.
- Who it may be relevant to
- Registry conditions: Biliary Tract Cancer, Advanced Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug 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, ora
Primary outcome measures
- Objective Response Rate (ORR) at 24 Weeks [Time frame: From treatment initiation until 24 weeks (or disease progression, if earlier).]
Secondary outcome measures (5)
- Progression-Free Survival (PFS) [Time frame: Up to 2 years.]
- Overall Survival (OS) [Time frame: Up to 2 years.]
- Disease Control Rate (DCR) [Time frame: Up to 2 years.]
- Duration of Response (DOR) [Time frame: Up to 2 years.]
- Incidence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: From first dose until 30 days after last dose.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07003815 · TJ-IRB202401114