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

NCT ID: NCT05215665

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2026-01-15

Brief Summary

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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

Detailed Description

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Conditions

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Cholangiocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group 1

GEMOX+Lenvatinib+Toripalimab

Group Type EXPERIMENTAL

GEMOX Regimen

Intervention Type DRUG

Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W

Lenvatinib

Intervention Type DRUG

8/12mg PO QD continuously

Toripalimab

Intervention Type DRUG

240mg IV d1 Q3W

group 2

GEMOX+Toripalimab

Group Type EXPERIMENTAL

GEMOX Regimen

Intervention Type DRUG

Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W

Toripalimab

Intervention Type DRUG

240mg IV d1 Q3W

Interventions

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GEMOX Regimen

Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W

Intervention Type DRUG

Lenvatinib

8/12mg PO QD continuously

Intervention Type DRUG

Toripalimab

240mg IV d1 Q3W

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Liu, MD

Role: CONTACT

Phone: +86 22-27468682

Email: [email protected]

Ningning Zhang, MD

Role: CONTACT

Phone: 15822153931

Email: [email protected]

Facility Contacts

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Wei Lu, MD

Role: primary

Ningning Zhang, MD

Role: backup

Other Identifiers

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GTIC

Identifier Type: -

Identifier Source: org_study_id