- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05023109
GP Chemotherapy in Combination With Anti-PD-1 and Anti-TIGIT in Unresectable Advanced BTC
A Study to Evaluate GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Participants With Unresectable Advanced Biliary Tract Carcinoma (BTC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Biliary Tract Carcinoma (BTC) has an insidious onset, invasiveness, high malignancy, and no specific symptoms in the early stage, and most of them are in the middle and advanced stages at the time of diagnosis and have lost the chance of surgery. For patients with advanced BTC, systemic therapy is currently the main choice, and gemcitabine/cisplatin (GP) is currently the "gold standard" for first-line treatment of advanced BTC, but the efficacy is still unsatisfactory, and more and more clinical practice has found that GP-based combination therapy may have better efficacy.
Previous studies have shown that chemotherapy can improve the immunotherapy microenvironment and may have a synergistic anti-tumor effect in combination with immunotherapy. This study is to explore the efficacy and safety of GP in combination with anti-PD1 antibody (Tislelizumab) and anti-TIGIT antibody (Ociperlimab) as first-line treatment in participants with unresectable advanced BTC.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Shanghai, China, 200032
- Zhongshan Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Subjects with a histopathological or cytologically diagnosis of BTC
- The participants must be required to sign an informed consent
- At least one measurable lesion (RECIST 1.1)
- No previous systematic treatment for BTC
- Child-Pugh Score, Class A
- ECOG performance status 0 or 1
- Adequate organ function
- Life expectancy of at least 3 months
Exclusion Criteria:
• Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma
- Known history of a serious allergy to any monoclonal antibody
- Known central nervous system metastases and/or leptomeningeal disease prior to treatment
- Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment
- Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
- Any active malignancy prior to the start of treatment
- Active or history of autoimmune disease
- Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
- Pregnant or lactating women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GP+PD-1+Tight
Tislelizumab 200mg IV Q3W + Ociperlimab 900mg IV Q3W + GP (gemcitabine 1000mg/m2 + cisplatin 25mg/m2 Q3W) Gemcitabine/Cisplatin will be administered on D1/D8 in every three weeks cycle and up to 8 cycles. Tislelizumab and Ociperlimab will be administered on D1 in every three weeks cycle, until the disease progression, intolerable toxicity, death, withdrawal of consent. |
Drug: Tislelizumab Tislelizumab 200mg IV Q3W Other Name: BGB-A317 Anti-PD-1 therapy Drug: Ociperlimab Ociperlimab 900mg IV Q3W Other Name: BGB-A1217 Anti-TIGIT therapy Drug: GP chemotherapy gemcitabine 1000mg/m2 + cisplatin 25mg/m2 Q3W |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: 24 months
|
ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate (DCR)
Time Frame: 24 months
|
DCR is defined as the proportion of subjects with CR or PR or SD to study drugs
|
24 months
|
Duration of response (DoR)
Time Frame: 24 months
|
DoR is defined as the time interval from first meeting response criteria (CR or PR) to confirmed progressive disease (PD) or death, whichever occurs first.
|
24 months
|
Progression-free survival (PFS)
Time Frame: 24 months
|
PFS is defined as the time from the date of treatment to the first documented disease progression or death due to any cause, whichever occurs first.
|
24 months
|
6-months/12-months PFS rate
Time Frame: 6 months/12 months
|
6-months/12-months PFS rate is defined as the proportion of patients alive and free of disease progression at 6 months/12 months.
|
6 months/12 months
|
Overall Survival (OS)
Time Frame: 24 months
|
OS is defined as the time from the treatment until death due to any cause.
|
24 months
|
6-months/12-months OS rate
Time Frame: 6 months/12 months
|
OS rate is defined as the proportion of patients who have not experienced death from any cause at 6 months/12 months.
|
6 months/12 months
|
Adverse Events (AEs)
Time Frame: 24 months
|
The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jia Fan, Shanghai Zhongshan Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZSAB-TOP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Biliary Tract Carcinoma
-
Brno University HospitalRecruitingBiliary Tract Carcinoma | Biliary ObstructionCzechia
-
The First Affiliated Hospital with Nanjing Medical...Recruiting
-
Fudan UniversityRecruitingBiliary Tract CarcinomaChina
-
Fudan UniversityActive, not recruitingBiliary Tract Carcinoma | Initially UnresectableChina
-
AstraZenecaRecruitingHepatocellular Carcinoma | Biliary Tract CancerChina, Spain, Korea, Republic of, Italy, United Kingdom, United States, Japan, Taiwan, Hong Kong
-
Krankenhaus NordwestGerman Research FoundationRecruitingBiliary Tract Cancer | Incidental Gallbladder CarcinomaGermany
-
Massachusetts General HospitalAstraZenecaRecruitingHepatocellular Carcinoma | Biliary Tract CancerUnited States
-
Tongji HospitalRecruitingHepatocellular Carcinoma | Biliary Tract CancerChina
-
Asan Medical CenterRecruitingHepatocellular Carcinoma | Biliary Tract CancerKorea, Republic of
-
CSPC Ouyi Pharmaceutical Co., Ltd.Not yet recruitingIntrahepatic Cholangiocarcinoma | Gallbladder Carcinoma | Advanced Biliary Tract Cancer | Extrahepatic CholangiocarcinomaChina
Clinical Trials on GP+PD-1+Tight
-
Fudan UniversityWithdrawnIntrahepatic CholangiocarcinomaChina
-
Guangxi Medical UniversityWuzhou Red Cross Hospital; Wuhan Union Hospital, China; Yunnan Cancer Hospital; Hainan People's Hospital and other collaboratorsNot yet recruitingNasopharyngeal Carcinoma | Neoadjuvant Therapy | PD-1 Inhibitor
-
Sun Yat-sen UniversityRecruitingRecurrent Nasopharyngeal CarcinomaChina
-
Shanghai Zhongshan HospitalRecruiting
-
RWJ Barnabas Health at Jersey City Medical CenterUnknown
-
French National Agency for Research on AIDS and...Aventis PharmaceuticalsTerminated
-
Peking UniversityNot yet recruitingGastroesophageal Junction Cancer | Chemoradiotherapy | PD-1
-
The First Affiliated Hospital of Guangdong Pharmaceutical...University of Technology, Sydney; Guangzhou Anjie Biomedical Technology Co....UnknownNon-small Cell Lung Cancer | Lung Neoplasm MalignantChina
-
Shanghai Chest HospitalNot yet recruitingEsophageal CancerChina
-
University of Colorado, DenverNational Cancer Institute (NCI); Cancer League of ColoradoWithdrawnColorectal Cancer | Microsatellite Instability High | Mismatch Repair DeficiencyUnited States