Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX in Advanced Intrahepatic Cholangiocarcinoma

February 22, 2022 updated by: Tianjin Medical University Cancer Institute and Hospital

A Phase II Study of Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX as First-line Therapy in Patients With Advanced Intrahepatic Cholangiocarcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ningning Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group1
Sintilimab Combined With GEMOX + IBI305
Drug: Sintilimab
200mg IV d1 Q3W
Drug: IBI305
7.5mg/kg IV d1 Q3W
Other Names:
  • Bevacizumab Biosimilar
Drug: GEMOX
Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W
Experimental: experimental group2
Sintilimab Combined With GEMOX
Drug: Sintilimab
200mg IV d1 Q3W
Drug: GEMOX
Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W
Active Comparator: Comparator
GEMOX
Drug: GEMOX
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)
Time Frame: 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
up to 90 days after last treatment administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event
Time Frame: up to 30 days after last treatment administration
All grades of adverse events, all grades of treatment related adverse events, serious of adverse events
up to 30 days after last treatment administration
Disease Control Rate (DCR)
Time Frame: 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
up to 90 days after last treatment administration
Progression free survival (PFS)
Time Frame: up to 3 years
the time period from randomization of the participants to objective tumor progression or death
up to 3 years
Overall survival (OS)
Time Frame: up to 3 years
the time period from the randomization of the participants to the death event due to any reason
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Investigators

  • Principal Investigator: Wei Lu, MD, Tianjin Medical University Cancer Institute & Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2022

Primary Completion (Anticipated)

January 13, 2024

Study Completion (Anticipated)

January 13, 2025

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

February 22, 2022

First Posted (Actual)

February 23, 2022

Study Record Updates

Last Update Posted (Actual)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGBICC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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