Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT05215665

GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma

Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-12-11

146

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The clinical trial is designed to evaluate the safety and efficacy of GEMOX combined with targeted therapy and immunotherapy for patients with advanced cholangiocarcinoma, and screen the potential biomarkers

CONDITIONS

Official Title

GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, 18 years old 64 70 years old
  • ECOG PS scores 0-1
  • Expected survival time > 12 weeks
  • Advanced cholangiocarcinoma confirmed by histopathology and/or cytology, locally advanced (inoperable) or distant metastasis, with at least one measurable untreated lesion (per RECIST 1.1 criteria)
  • No previous systemic or local treatment for the tumor
  • Sufficient organ and bone marrow function
Not Eligible

You will not qualify if you...

  • Other malignant tumors in the past 5 years (except radical basal cell carcinoma or squamous carcinoma of the skin, or radical resected carcinoma in situ)
  • Ampullary tumor
  • Treatment from other clinical trials within 4 weeks before first dose
  • Previous anti-PD-1, anti-PD-L1/L2, anti-CTLA4 antibodies, or other immunotherapy
  • Severe cardiovascular disease within 12 months before enrollment (e.g., symptomatic coronary heart disease, congestive heart failure 65 Grade II, uncontrolled arrhythmia, myocardial infarction)
  • Uncontrollable pleural effusion, pericardial effusion, or ascites
  • Use of steroids or systemic immunosuppressive therapies 4 weeks before enrollment
  • Allergic reactions to study drugs
  • HIV antibody positive, active hepatitis B or C
  • History of allogeneic organ or hematopoietic stem cell transplantation
  • Other conditions deemed inappropriate by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Actively Recruiting

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Research Team

W

Wei Liu, MD

CONTACT

N

Ningning Zhang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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