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

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05251662
• Other study ID #: SGBICC
• Status: Recruiting
• Phase: Phase 2
• Start date: January 13, 2022
• Est. completion date: January 13, 2025

Study information

• Verified date: January 2022
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Wei Lu, MD
• Phone: +86 22-27468682
• Email: mail4luwei[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 13, 2025
• Est. primary completion date: January 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Intervention

Drug:
• Sintilimab
200mg IV d1 Q3W
• IBI305
7.5mg/kg IV d1 Q3W
• GEMOX
Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

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