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

Not Applicable

Recruiting

• Conditions: Cholangiocarcinoma
• Interventions: Drug: GEMOX Regimen; Drug: Lenvatinib; Drug: Toripalimab

• Registration Number: NCT05215665
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-15
• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-01-31
• Status Verified: 2024-05
• Primary Completion: 2024-05-15
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-11
• Study Completion: 2026-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	GEMOX Regimen	GEMOX+Lenvatinib+Toripalimab
group 1	Lenvatinib	GEMOX+Lenvatinib+Toripalimab
group 1	Toripalimab	GEMOX+Lenvatinib+Toripalimab
group 2	GEMOX Regimen	GEMOX+Toripalimab
group 2	Toripalimab	GEMOX+Toripalimab

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	up to 90 days after last treatment administration	Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute & Hospital; 🇨🇳 Tianjin, Tianjin, China