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Durvalumab and Lenvatinib With or Without Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer

NCT05935579 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-15

No results posted yet for this study

Summary

Explore the impact of the first-line application of Durvalumab combined with Lenvatinib, with or without chemotherapy, on the survival, disease progression, and drug safety of patients with advanced biliary tract cancers.

Conditions

  • Biliary Tract Neoplasms
  • Immunotherapy

Interventions

DRUG

Durvalumab

Durvalumab 1500 mg will be administered intravenously once every three weeks, with intravenous infusion on Day 1 of each cycle.

DRUG

Lenvatinib Oral Product

The dose of lenvatinib is 12mg/day for patients with a body weight of ≥60 kg, and 8mg/day for patients with a body weight of \<60 kg, taken once daily.

DRUG

Chemotherapy

GEMOX regimen: Gemcitabine 1000mg/m2 will be administered intravenously over 30 minutes on Day 1 and Day 8; Oxaliplatin 100mg/m2 will be administered intravenously over 2 hours on Day 1, and the cycle will be repeated every 3 weeks.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-14
Primary Completion
2023-12-30
Completion
2024-12-30

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 NCT05935579 on ClinicalTrials.gov