Trials Sponsors Conditions Drugs Pricing

Conditions

Biliary Tract Cancer Biliary Tract Cancer (CCA)

Keywords

Adebrelimab

Outcome Measures

Primary Outcomes (1)

ORR
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
At the end of Cycle 6 and 10 (each cycle is 21 days)

Secondary Outcomes (4)

DCR
up to 18 months
PFS
up to 24 months
AE
up to 24 months
OS
up to 24 months

Study Arms (1)

Adebrelimab combined with the GC regimen and Apatinib

EXPERIMENTAL

Adebrelimab 1200mg, intravenous infusion, on day 1, repeated every 3 weeks; Gemcitabine 1000mg/m2, on days 1 and 8, every 3 weeks Cisplatin 50mg/m2, on day 1, every 3 weeks Apatinib 250mg, once daily, orally

Drug: Adebrelimab combined with the GC regimen and Apatinib

Interventions

Adebrelimab combined with the GC regimen and ApatinibDrug

Adebrelimab combined with the GC regimen and Apatinib

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Treatment programme
Adebrelimab combined with the GC regimen and Apatinib
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry record

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

\- 1. Pathological or histological diagnosis of malignant tumor of the biliary tract; 2. Patients who are classified as TxNx and TxNxM1 according to the UICC/AJCC TNM staging system (9th edition, 2024), and who, based on the judgment of the research team, meet the criteria for newly diagnosed incurable cases or are not suitable for surgery; 3. Age: 18-80 years old; 4. Expected survival period \> 3 months; 5. Both genders are eligible; 6. ECOG PS score of 0 or 1; 7. No severe complications, such as hypertension, coronary heart disease, and history of mental illness, no severe allergy history; non-pregnant and non-lactating; 8. The patient's organ and hematological system functions meet the following requirements:

Sponsors & Collaborators

Yongjun Chen
Otherlead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Yongjun Chen Yongjun ChenCONTACT027-83662379 yjchen@tjh.tjmu.edu.cn

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Central Study Contacts

Yongjun Chen Yongjun Chen

CONTACT

027-83662379 yjchen@tjh.tjmu.edu.cn

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Director

Study Record Dates

First Submitted

August 14, 2025

First Posted

August 22, 2025

Study Start

August 14, 2025

Actual (reported)

Primary Completion

June 30, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

You may not qualify if:

\. Patients who received immune checkpoint inhibitors before enrollment, or those who directly received another stimulatory or co-inhibitory T-cell receptor (such as CTLA-4, CD137); 2. Patients who used any other investigational drug within 4 weeks before enrollment; 3. Patients with any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy); children with asthma who have completely recovered after adulthood and do not require any intervention can be included, but patients requiring bronchodilator drug intervention cannot be included; 4. Congenital or acquired immune deficiencies, such as infection with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA \> 500 IU/ml), hepatitis C (positive hepatitis C antibody, HCV-RNA above the detection limit of the analytical method), or co-infection of hepatitis B and hepatitis C; 5. Serious infections occurred within 4 weeks before the first administration (such as intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever \> 38.5°C during screening or before the first administration; 6. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Having an uncontrolled mental disorder; 8. Concurrently having severe and/or uncontrollable diseases that may affect the participation in the study, such as unstable angina pectoris, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, poorly controlled diabetes, excessive activity, uncontrollable infection after insufficient biliary drainage (such as tumor blocking the bile duct); 9. Other cancers that occurred in the past (within the past 5 years) or simultaneously, excluding non-melanoma skin cancer and carcinoma in situ; 10. History of allergy or hypersensitivity to any study drug or any monoclonal antibody; 11. Unable or unwilling to sign the informed consent form.

A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initially Unresectable Biliary Tract Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Adebrelimab combined with the GC regimen and Apatinib

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Adebrelimab combined with the GC regimen and Apatinib

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations