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Pemigatinib Combined With PD-1 Inhibitor in Unresectable or Metastatic Intrahepatic Cholangiocarcinoma

NCT05913661 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-06-22

No results posted yet for this study

Summary

This is a Prospective, single-arm, phase II study with multicenter participation. The objective of this study is to evaluate the efficacy and safety of pemigatinib combined with PD-1 inhibitor as first-line treatment for patients with advanced unresectable or metastatic intrahepatic cholangiocarcinoma.

Conditions

  • Carcinoma
  • Intrahepatic Cholangiocarcinoma
  • Digestive System Neoplasms
  • PD-1 Inhibitor
  • First-line Treatment

Interventions

DRUG

Pemigatinib

Pemigatinib is scheduled to be administered at a dose of 13.5 mg quaque die according to a 2-week dosing and 1-week discontinuation regimen.

DRUG

PD-1 Inhibitors

The dosing regimen is 200 mg IV Q3W

Sponsors & Collaborators

  • First Affiliated Hospital of Jinan University

    collaborator OTHER

  • Shenzhen University General Hospital

    collaborator OTHER

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Lei Zhang, PHD · Sun Yat-Sen Memorial Hospital of 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
2023-07-31
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • China

Study Locations

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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 NCT05913661 on ClinicalTrials.gov