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

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05215665
• Other study ID #: GTIC
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: January 15, 2026

Study information

• Verified date: January 2022
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Wei Liu, MD
• Phone: +86 22-27468682
• Email: mail4luwei[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 15, 2026
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

Drug:
• GEMOX Regimen
Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W
• Lenvatinib
8/12mg PO QD continuously
• Toripalimab
240mg IV d1 Q3W

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR	up to 90 days after last treatment administration
Primary	The frequency, duration, and severity of adverse events	Safety is assessed by the frequency, duration, and severity of adverse events	up to 30 days after last treatment administration
Secondary	Disease Control Rate (DCR)	Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR?PR or SD	up to 90 days after last treatment administration
Secondary	Progression free survival (PFS)	the time period from randomization of the participants to objective tumor progression or death	up to 3 years
Secondary	Overall survival (OS)	the time period from the randomization of the participants to the death event due to any reason	up to 3 years