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

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

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

Study Overview

• Status: Recruiting
• Conditions: Cholangiocarcinoma
• Intervention / Treatment: Drug: Lenvatinib; Drug: Toripalimab; Drug: GEMOX Regimen

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ningning Zhang, MD; Phone Number: 15822153931; Email: mail4ningning@163.com
• Study Contact Backup: Name: Wei Liu, MD; Phone Number: +86 22-27468682; Email: mail4luwei@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Medical University Cancer Institute & Hospital
      • Contact: Wei Lu, MD; Phone Number: +86 22-27468682; Email: mail4luwei@163.com
      • Contact: Ningning Zhang, MD; Phone Number: 15822153931; Email: mail4ningning@163.com
      • Sub-Investigator: Ningning Zhang, MD
      • Principal Investigator: Wei Lu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1; GEMOX+Lenvatinib+Toripalimab	Drug: Lenvatinib; 8/12mg PO QD continuously; Drug: Toripalimab; 240mg IV d1 Q3W; Drug: GEMOX Regimen; Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W
Experimental: group 2; GEMOX+Toripalimab	Drug: Toripalimab; 240mg IV d1 Q3W; Drug: GEMOX Regimen; Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Progression free survival (PFS)	the time period from randomization of the participants to objective tumor progression or death	up to 3 years
Overall survival (OS)	the time period from the randomization of the participants to the death event due to any reason	up to 3 years
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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): May 15, 2024
• Study Completion (Estimated): January 15, 2026

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Cholangiocarcinoma; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Lenvatinib
• Other Study ID Numbers: GTIC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No