Recruiting
Efficacy, Safety Evaluation and Biomarker Screening of GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma
What is being tested
GEMOX Regimen
+ Lenvatinib
+ Toripalimab
Drug
Who is being recruted
Adenocarcinoma+3
+ Carcinoma
+ Neoplasms
From 18 to 70 Years
+17 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: January 2022
Summary
Principal SponsorTianjin Medical University Cancer Institute and Hospital
Study ContactWei Liu, MDMore contacts
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: January 15, 2022
Actual date on which the first participant was enrolled.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
Official TitleEfficacy, Safety Evaluation and Biomarker Screening of GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma
Principal SponsorTianjin Medical University Cancer Institute and Hospital
Study ContactWei Liu, MDMore contacts
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
146 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
AdenocarcinomaCarcinomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialCholangiocarcinoma
Criteria
6 inclusion criteria required to participate
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)
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11 exclusion criteria prevent from participating
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
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGEMOX+Lenvatinib+Toripalimab
Group II
ExperimentalGEMOX+Toripalimab
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, ChinaOpen Tianjin Medical University Cancer Institute & Hospital in Google MapsRecruiting
One Study Center