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

Last updated: February 22, 2022
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Biliary Tract Cancer

Abdominal Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT05251662
SGBICC
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent should be signed before implementing any trial-relatedprocedures
  • Male or female, 18 years old ≤ age ≤ 75 years old
  • Histopathologically or cytologically diagnosed as locally advanced intrahepaticcholangiocarcinoma
  • No previous systemic treatment, More than 6 months after the end of postoperativeadjuvant 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

Exclusion Criteria:

  • Suffered from other malignant tumors in the past 5 years (except Radical basal cellcarcinoma of the skin squamous carcinoma of the skin and/or radical resected carcinomain 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 otherimmunotherapy
  • Suffered from severe cardiovascular disease within 12 months before enrollment, suchas 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 stemcell transplantation
  • other conditions that the investigator deems inappropriate for enrollment.

Study Design

Total Participants: 90
Study Start date:
January 13, 2022
Estimated Completion Date:
January 13, 2025

Connect with a study center

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

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