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

  • STATUS
    Recruiting
  • End date
    Jan 15, 2026
  • participants needed
    120
  • sponsor
    Tianjin Medical University Cancer Institute and Hospital
Updated on 25 March 2022
measurable disease
metastasis
oxaliplatin
gemcitabine

Summary

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

Details
Condition Cholangiocarcinoma
Treatment Lenvatinib, Toripalimab, GEMOX Regimen, GEMOX Regimen
Clinical Study IdentifierNCT05215665
SponsorTianjin Medical University Cancer Institute and Hospital
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, 18 years old ≤ age ≤ 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, and with at least one measurable lesion that has not been locally treated (per RECIST 1.1 criteria)
Not received any previous systemic or local treatment for the tumor
Sufficient organ and bone marrow function

Exclusion Criteria

Suffered from other malignant tumors in the past 5 years (except Radical basal cell carcinoma of the skin squamous carcinoma of the skin and/or radical resected carcinoma in situ)
Ampullary tumor
Received treatment from other clinical trials within 4 weeks before the first dose
Received any anti-PD-1 antibody, anti-PD-L1/L2 antibody, anti-CTLA4 antibody, or other immunotherapy
Suffered from severe cardiovascular disease within 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure ≥ Grade II, uncontrolled arrhythmia, and myocardial infarction
Uncontrollable pleural effusion, pericardial effusion or ascites
Use steroids or other systemic immunosuppressive therapies 4 weeks before enrollment
Allergic reactions to the drugs used in this study
HIV antibody positive, active hepatitis B or C (HBV, HCV)
Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
other conditions that the investigator deems inappropriate for enrollment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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