NCT07003815Not yet recruitingPhase 2
Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer
A Single-Arm, Exploratory Clinical Study of Envafolimab Combined With Gemcitabine, Cisplatin, and Simvastatin for the Treatment of Locally Advanced or Metastatic BTC Patients
Source: ClinicalTrials.gov · Last updated 4 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 27 May 2025
- Start date
- Jun 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Tongji Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07003815
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 62
- From Jun 2025 to the primary completion date, Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Autoimmune Disease : Active or previously documented autoimmune/inflammatory disorders.
- Recent Trials : Participation in other drug/device trials within 4 weeks prior to enrollment.
Other illness
- Disease Type : Ampulla of Vater cancer.
- Allergy : Hypersensitivity to any study drug (Envafolimab, gemcitabine, cisplatin, or simvastatin).
- Psychiatric History : Severe psychiatric disorders.
- Investigator's Discretion : Any other condition deemed unsuitable for participation by the investigator.
Other
- Liver Function : Decompensated liver dysfunction.
- Compliance : Inability to adhere to protocol requirements or follow-up schedule.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.