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

Primary Purpose

Cholangiocarcinoma

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

GEMOX Regimen

Lenvatinib

Toripalimab

About this trial

This is an interventional treatment trial for Cholangiocarcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tianjin Medical University Cancer Institute & HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

group 1

group 2

group 3

group 4

Arm Description

Lenvatinib+Toripalimab

GEMOX+Lenvatinib+Toripalimab

Lenvatinib+Toripalimab (failure of GEMOX treatment)

GEMOX+Toripalimab

Outcomes

Primary Outcome Measures

Overall response rate (ORR)

Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR

The frequency, duration, and severity of adverse events

Safety is assessed by the frequency, duration, and severity of adverse events

Secondary Outcome Measures

Disease Control Rate (DCR)

Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR、PR or SD

Progression free survival (PFS)

the time period from randomization of the participants to objective tumor progression or death

Overall survival (OS)

the time period from the randomization of the participants to the death event due to any reason

Full Information

NCT ID

NCT05215665

First Posted

January 19, 2022

Last Updated

January 28, 2022

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05215665

Brief Title

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

Official Title

Efficacy, Safety Evaluation and Biomarker Screening of GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 15, 2022 (Actual)

Primary Completion Date

January 15, 2024 (Anticipated)

Study Completion Date

January 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholangiocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group 1

Arm Type

Experimental

Arm Description

Lenvatinib+Toripalimab

Arm Title

group 2

Arm Type

Experimental

Arm Description

GEMOX+Lenvatinib+Toripalimab

Arm Title

group 3

Arm Type

Experimental

Arm Description

Lenvatinib+Toripalimab (failure of GEMOX treatment)

Arm Title

group 4

Arm Type

Experimental

Arm Description

GEMOX+Toripalimab

Intervention Type

Drug

Intervention Name(s)

GEMOX Regimen

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Lenvatinib

Intervention Description

8/12mg PO QD continuously

Intervention Type

Drug

Intervention Name(s)

Toripalimab

Intervention Description

240mg IV d1 Q3W

Primary Outcome Measure Information:

Title

Overall response rate (ORR)

Description

Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR

Time Frame

up to 90 days after last treatment administration

Title

The frequency, duration, and severity of adverse events

Description

Safety is assessed by the frequency, duration, and severity of adverse events

Time Frame

up to 30 days after last treatment administration

Secondary Outcome Measure Information:

Title

Disease Control Rate (DCR)

Description

Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR、PR or SD

Time Frame

up to 90 days after last treatment administration

Title

Progression free survival (PFS)

Description

the time period from randomization of the participants to objective tumor progression or death

Time Frame

up to 3 years

Title

Overall survival (OS)

Description

the time period from the randomization of the participants to the death event due to any reason

Time Frame

up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei Liu, MD

Phone

+86 22-27468682

mail4luwei@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ningning Zhang, MD

Phone

15822153931

mail4ningning@163.com

Facility Information:

Facility Name

Tianjin Medical University Cancer Institute & Hospital

City

Tianjin

State/Province

Tianjin

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei Lu, MD

Phone

+86 22-27468682

mail4luwei@163.com

First Name & Middle Initial & Last Name & Degree

Ningning Zhang, MD

Phone

15822153931

mail4ningning@163.com

First Name & Middle Initial & Last Name & Degree

Wei Lu, MD

First Name & Middle Initial & Last Name & Degree

Ningning Zhang, MD

12. IPD Sharing Statement

Learn more about this trial

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

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