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Envofolimab and Lenvatinib Combined With Gemcitabine Plus Cisplatin for Advanced BTC as First-Line Treatment(ENLIGHTEN)

NCT05410197 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2022-10-12

No results posted yet for this study

Summary

This is a phase 2, single-arm, open label study. The purpose is to investigate both the efficacy and safety of Envofolimab and Lenvatinib in combination with Gemcitabine plus Cisplatin for treatment of advanced biliary tract cancer as first-line treatment.

Conditions

  • Advanced Biliary Tract Cancer

Interventions

DRUG

Envofolimab

400mg by subcutaneous injection every 3 weeks

DRUG

Lenvatinib

8 mg orally once a day

DRUG

Gemcitabine

1000mg/m2 by intravenous infusions on day 1 and 8 every 3 weeks for up to 24 weeks

DRUG

Cisplatin

25mg/m2 by intravenous infusions on day 1 and 8 every 3 weeks for up to 24 weeks

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ming Kuang, PhD · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2024-08-01
Completion
2025-08-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05410197 on ClinicalTrials.gov