NCT05215665

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

December 11, 2024

Status Verified

May 1, 2024

Enrollment Period

2.3 years

First QC Date

January 19, 2022

Last Update Submit

December 10, 2024

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Disease Control Rate (DCR)

    up to 90 days after last treatment administration

  • Progression free survival (PFS)

    up to 3 years

  • Overall survival (OS)

    up to 3 years

  • The frequency, duration, and severity of adverse events

    up to 30 days after last treatment administration

Study Arms (2)

group 1

EXPERIMENTAL

GEMOX+Lenvatinib+Toripalimab

Drug: GEMOX RegimenDrug: LenvatinibDrug: Toripalimab

group 2

EXPERIMENTAL

GEMOX+Toripalimab

Drug: GEMOX RegimenDrug: Toripalimab

Interventions

GEMOX RegimenDRUG

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

group 1group 2
LenvatinibDRUG

8/12mg PO QD continuously

group 1
ToripalimabDRUG

240mg IV d1 Q3W

group 1group 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

gemcitabine-oxaliplatin regimenlenvatinibtoripalimab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Wei Liu, MD

CONTACT

+86 22-27468682mail4luwei@163.com

Ningning Zhang, MD

CONTACT

15822153931mail4ningning@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2022

First Posted

January 31, 2022

Study Start

January 15, 2022

Primary Completion

May 15, 2024

Study Completion

January 15, 2026

Last Updated

December 11, 2024

Record last verified: 2024-05

Locations

CN(1)