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A Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin in Biliary Tract Malignancies

NCT06181032 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-04-30

No results posted yet for this study

Summary

Evaluating the efficacy and safety of adebrelimab in combination with apatinib, gemcitabine and cisplatin in the neoadjuvant treatment of patients with biliary tract malignancies.

Conditions

  • Biliary Tract Malignancies

Interventions

DRUG

Adebrelimab

Adebrelimab: 1200mg or 20mg/kg, iv, D1, Q3W;

DRUG

Apatinib

Apatinib: 250 mg, po, QD, Q3W;

DRUG

Gemcitabine

Gemcitabine: 1000 mg/m2, iv, 30min, D1, D8, Q3W;

DRUG

Cisplatin

Cisplatin: 25 mg/m2, iv, 30min, D1, D8, Q3W; Injection sequence: adebelizumab → gemcitabine → cisplatin (sequential interval of at least 30 min), 3 cycles of neoadjuvant therapy.

Sponsors & Collaborators

  • First Affiliated Hospital of Fujian Medical University

    lead OTHER

Principal Investigators

  • Yufeng Chen · Zhangzhou Hospital of Fujian Medical University

  • Maolin Yan · Fujian Provincial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-12-23
Primary Completion
2029-02-23
Completion
2029-02-23

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 NCT06181032 on ClinicalTrials.gov