NCT05251662

Brief Summary

A randomized controlled, phase II clinical trial is designed to compare the safety and efficacy of Sintilimab combined with GEMOX ± IBI305 and GEMOX as first-line therapy in advanced intrahepatic cholangiocarcinoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 11, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

January 13, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2025

Completed
Last Updated

February 23, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

January 11, 2022

Last Update Submit

February 22, 2022

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

Intrahepatic CholangiocarcinomaFirst-line TherapySintilimabIBI305GEMOX

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

  • Adverse event

    up to 30 days after last treatment administration

Study Arms (3)

experimental group1

EXPERIMENTAL

Sintilimab Combined With GEMOX + IBI305

Drug: SintilimabDrug: IBI305Drug: GEMOX

experimental group2

EXPERIMENTAL

Sintilimab Combined With GEMOX

Drug: SintilimabDrug: GEMOX

Comparator

ACTIVE COMPARATOR

GEMOX

Drug: GEMOX

Interventions

SintilimabDRUG

200mg IV d1 Q3W

experimental group1experimental group2
IBI305DRUG

7.5mg/kg IV d1 Q3W

Also known as: Bevacizumab Biosimilar
experimental group1
GEMOXDRUG

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

Comparatorexperimental group1experimental group2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent should be signed before implementing any trial-related procedures
  • Male or female, 18 years old ≤ age ≤ 75 years old
  • Histopathologically or cytologically diagnosed as locally advanced intrahepatic cholangiocarcinoma
  • No previous systemic treatment, More than 6 months after the end of postoperative adjuvant therapy was allowed
  • Expected survival time \> 3 months
  • At least ≥ 1 measurable lesions per RECIST 1.1
  • ECOG PS scores 0-2
  • Sufficient organ and bone marrow function
  • Urine or serum pregnancy test is negative

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, 300060, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

sintilimab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Wei Lu, MD

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Lu, MD

CONTACT

+86 22-27468682mail4luwei@163.com

Ningning Zhang, MD

CONTACT

15822153931mail4ningning@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

February 23, 2022

Study Start

January 13, 2022

Primary Completion

January 13, 2024

Study Completion

January 13, 2025

Last Updated

February 23, 2022

Record last verified: 2022-01

Locations

CN(1)