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

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Bile duct cancer
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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

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

Study Type

Interventional

Primary Outcome

Overall response rate (ORR)

Secondary Outcome

 Disease Control Rate (DCR)

Condition

Cholangiocarcinoma

Intervention

GEMOX Regimen

Study Arms / Comparison Groups

 group 1
Description:  Lenvatinib+Toripalimab

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

120

Start Date

January 15, 2022

Completion Date

January 15, 2026

Primary Completion Date

January 15, 2024

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

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, +86 22-27468682, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT05215665

Organization ID

GTIC

Responsible Party

Sponsor

Study Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study Sponsor

, ,

Verification Date

January 2022